A Passionate Helping Hand Home Health Care LLC

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure visit notes were complete, dated, and signed for 4 of 8 active clinical records reviewed. (Patients #1, #4, #6, and #7) Findings Include: 1. A policy titled “Clinical Record Review”, revised April 2019, indicated but was not limited to, “ … Clinical records will be reviewed … to assure that documentation entered is reliable, timely, valid, and accurate …” 2. A review of Patient #1’s clinical record evidenced a POC with a SOC of 01/12/2023 and a certification period from 01/01/2025 to 03/01/2025. The POC included the following diagnoses: Infection/Inflammatory reaction due to internal left hip prosthetic, Hypertension (high blood pressure), chronic pain syndrome, right hip osteoarthritis (degeneration of the cartilage causing friction on the bones), Hematuria (blood in the urine), and a history of falls. The POC evidenced the patient received HHA services three times a week for one week and five times a week for eight weeks. Reviewed HHA visit notes from 12/30/2024 through 02/06/2025. The HHA visit notes dated 01/06, 01/07, 01/08, 01/10, 01/13, and 01/14/2025 evidenced under the section titled “Signature”, indicated “HHA”. The visit notes failed to be signed and dated by the HHA. During an interview with HHA 1 on 02/07/2025 at 7:45 AM, they indicated they provided care for Patient #1 five days a week. They explained their visit notes were supposed to be completed and submitted after every visit. 3. A review of Patient #4’s clinical record evidenced a POC with a SOC of 09/22/2023 and a certification period from 01/14/2025 to 03/14/2025. The POC included the following diagnoses: Spastic Quadriplegic Cerebral Palsy (a condition affecting all four extremities causing muscle stiffness and limited movement with speaking difficulties and developmental disabilities), Bronchopulmonary dysplasia (lung disease causing inflammation in the lungs from premature birth), Chronic Kidney Disease (long-term condition where the kidneys have difficulty filter waste in the body), and Gastrostomy status (a tube surgically placed in the abdomen to bring nutrients and medication into the stomach). The POC evidenced the patient received HHA visits eight times a week for one week and ten visits a week for eight weeks. Reviewed HHA visit notes from 12/30/2024 to 02/07/2025. The HHA visit notes dated 01/01/2025, 01/02/2025, 01/03/2025, 01/06/2025, 01/07/2025, 01/08/2025, 01/09/2025, 01/10/2025, 01/13/2025, 01/14/2025, 01/15/2025, 01/16/2025, 01/17/2025, 01/20/2025, 01/21/2025, 01/22/2025, and 01/23/2025 failed to evidence the clinicians signed and dated the documents. The HHA visit notes dated 01/24/2025, 01/27/2025, 01/29/2025, 01/30/2025, 01/31/2025, 02/03/2025, 02/04/2025, 02/05/2025 failed to evidence the clinicians included the tasks they completed and signed and dated the visit note. During an interview with HHA 7 on 02/07/2025 at 1:11 PM, they indicated they provided care to Patient #4 from 4:00 PM to midnight during the week days. They explained visit notes were to be completed right after they clocked out. They indicated they were to complete the document and sign and date it as well. During an interview with HHA 8 on 02/07/2025 at 3:03 PM, they indicated they provided care for Patient #4 from 8:00 AM to 4:00 PM during the weekdays. They explained they were to complete visits every day and include all the tasks they completed with the patient. They explained the visits were signed and dated when the document was completed. 4. A review of Patient #6’s clinical record evidenced a POC with a SOC of 08/24/2024 and a certification period from 12/25/2024 to 02/22/2025. The POC included the following diagnoses: Dementia (cognitive decline impacting thinking in everyday life), unspecified psychosis (a mental health condition where a person has a loss of reality), Hypertension, Chronic Obstructive Pulmonary Disease (lung disease causing obstructed air flow and breathing problems), and Supraventricular tachycardia (a fast heart rate starting in the upper chambers of the heart). The POC evidenced the patient received six visits a week for one week and ten visits a week for eight weeks. Reviewed HHA visit notes from 12/25/2024 through 02/07/2025 in Patient #6’s record. The visit notes dated 12/26/2024, 12/27/2024, 12/30/2024, 12/30/2024, 12/31/2024, 01/01/2025, 01/02/2025, 01/03/2025, 01/06/2025, 01/07/2025, 01/08/2025, 01/10/2025, 01/13/2025, 01/14/2025, 01/15/2025, 01/17/2025, 01/20/2025, 01/22/2025, 01/23/2025, 01/24/2025, and 01/28/2025 failed to evidenced they were signed and dated by the clinicians. A review of the HHA visit note in Patient #6’s record dated 12/27/2024 and timed 6:59 AM to 12:00 PM failed to evidence the tasks completed and the signature and date of completion by the clinician. During an interview with HHA 4 on 02/07/2025 at 12:05 PM, they indicated they provided care for Patient #6 Mondays through Fridays from 8:00 AM to 3:00 PM. They explained the visit notes were to include the tasks they completed, the date, and their signature before the end of their shift every day. They indicated the Administrator asked them to complete their visits in two different electronic medical records, System 2 and System 3. During an interview with HHA 5 on 02/07/2025 at 1:38 PM, they indicated they provided care for Patient #6 in the afternoons and evening Mondays through Fridays. They explained they completed their visit notes before they left the patient’s residence. 5. A review of Patient #7’s clinical record evidenced a POC with a SOC of 01/10/2023 and a certification period from 12/30/2024 to 02/27/2025. The POC evidenced the following diagnoses: Chronic Obstructive Pulmonary disease, Hypertensive Heart Disease with Heart Failure (prolonged high blood pressure causing damage to the heart muscles), Type 2 Diabetes (a condition where the body is unable to regulate blood sugar appropriately) with diabetic chronic kidney disease (a condition where the kidneys are damaged because of long-term high blood sugar) and peripheral angiopathy (inflammation and narrowing of the blood flow in the legs). The POC indicated the patient received HHA services five times a week for eight weeks and four times a week for one. Reviewed HHA visit notes from 12/30/2024 to 02/06/2025. The visit notes dated 01/28/2024, 01/31/2024, 02/03/2025, 02/04/2025, and 02/05/2025 failed to evidence the tasks HHA 6 performed for Patient #7. During an interview with HHA 6 on 02/07/2025 at 3:11 PM, they explained visit documents were to be completed at the end of their shift with the tasks they performed and submitted into the clinical record. 6. During an interview with the Administrator on 02/07/2025 at 2:45 PM, they explained how the clinicians were to complete, sign, and date their documents in both electronic medical record systems, System 2 and System 3. 410 IAC 17-15-1(a)(7)”

“Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms “facility” or “facilities” in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive emergency preparedness program met all requirements to meet the health, safety, and security needs of their staff and patient population for 1 of 1 agency (E0001); failed to ensure an Emergency Preparedness Plan was in place and reviewed every 2 years, at minimum (E0004); failed to ensure a facility based and community based risk assessment utilizing an all-hazards approach (E0006); failed to ensure patients had written and individualized Emergency Preparedness plans, included as part of their comprehensive assessments, in 8 of 8 clinical records reviewed (E0017), failed to ensure the agency had a plan for the subsistence needs for staff and patients, whether they evacuated or sheltered in place; failed to ensure access to a plan or a system / defined procedure to track the location of on-duty staff and sheltered patients under the agency’s care during an emergency (E0021); failed to ensure a system of medical documentation that would preserve patient information, protects the confidentiality of patient information , secures and maintains the availability of records (E0023); failed to ensure that an emergency preparedness communication plan included all staffing addresses and phone numbers, entities providing services under arrangements, and patient physicians for all districts/ territories that the agency provided services to (E0030; and failed to ensure all staff providing services in all districts / territories were trained in emergency preparedness and failed to ensure the agency maintained documentation of the training provided (E0037). The cumulative effect of these systemic problems resulted in the agency being found out of compliance with the condition, Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers for Home Health Agencies. at 42 CFR 484.102. Findings include: 1. A review of an agency’s policy titled ‘NATURAL DISASTER MANAGEMENT PLAN’ dated 03/20/2020 revealed, “PURPOSE To outline a planned, coordinated strategy to promote the safety and continuation of care, treatment and/or services … HHA patients in the event of a natural disaster. POLICY … HHA staff shall be informed of the Natural Disaster Management Plan during orientation and annually thereafter … HHA patients shall be informed of the Natural Disaster Management Plan during the admission process. PROCEDURE Staff information is kept current and updated …Computer patient and staff data is backed up daily … Active patient demographic and clinical data is updated on an ongoing basis … The Case Manager/Clinical Supervisor is responsible for maintaining an updated and current log of patients with special needs … at least weekly … PREPARATIONS FOR AN IMPENDING NATURAL DISASTER: During the time of a WATCH … staff will contact active patients to evaluate and assist with … arrangements … The clinical Supervisor or designees shall notify state and local emergency preparedness officials about any HHA patient in need of evacuation … Clinical Supervisors and the Human Resource Director will prepare hard copy lists of active patients and staff … At the time of WARNING OR EVACUATION status, the Administrator will activate … Emergency Operations Plan. If a warning occurs when the HHA is closed, staff are to contact their respective supervisors prior to reporting to work. In the event that telephone service is interrupted: HHA staff are to remain at home until notified … During office hours, the Clinical Supervisor will go to the nearest emergency authority with a list of patient names and addresses in order of priority code. After office hours, the on-call nurse will go to the nearest emergency authority with a list of patient names and addresses in order of priority code.” 2. A review of the agency’s emergency preparedness (EP) binder failed evidenced a current employee and patient rosters, failed to ensure an Emergency Preparedness Plan was reviewed every 2 years, at minimum, failed to ensure a facility based and community based risk assessment utilizing an all-hazards approach, failed to ensure patients had written and individualized Emergency Preparedness plans, included as part of their comprehensive assessments, failed to ensure the agency had a plan for the subsistence needs for staff and patients, whether they evacuated or sheltered in place; failed to ensure access to a plan or a system / defined procedure to track the location of on-duty staff and sheltered patients under the agency’s care during an emergency; failed to ensure a system of medical documentation that would preserve patient information, protects the confidentiality of patient information , secures and maintains the availability of records; failed to ensure that an emergency preparedness communication plan included all staffing addresses and phone numbers, entities providing services under arrangements, and patient physicians for all districts/ territories that the agency provided services to; and failed to ensure all staff providing services in all districts / territories were trained in emergency preparedness and failed to ensure the agency maintained documentation of the training provided . 3. On 03/01/2024 at 10:48 AM, the Administrator indicated they should know all the answers to Emergency Preparedness but is still learning and wished to have all questions deferred to the office manager. This writer asked the Administrator if they understood the Administrator is responsible for emergency preparedness, and they indicated they understood.”

“Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient’s rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This Condition is not met as evidenced by: Based on observation, record review and interview the agency failed to protect and promote patients’ rights by: failing to ensure patients or their legal representative were provided with: written notice of the patient’s rights and responsibilities, the agency’s transfer and discharge policies, and ensured they were understandable and accessible (see G0412), failed to ensure patient was furnished with contact information for the Administrator, including name, business address, and business phone number in order to receive complaints (see G0414), failed to ensure patient had been furnished with an OASIS privacy notice (see G0416), Based on observation, record review, and interview the agency failed to properly assess patients’ capacity to consent to receive services thereby failing to ensure patients retained the right to participate in their care (see G0434), failed to ensure the patient was furnished with the State Toll free Home Health Hotline Number (see G0444), failed to ensure the patient was furnished with the contact information for Federal and State funded entities (see G0446), the agency failed to ensure investigation of complaints made by patients or representatives (see G0478), the agency failed to document complaints made by patients or representatives or any resolution of the complaint (see G0484). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure patients received appropriate services which resulted in the agency not providing quality health care for all 54 patients. Findings include: *”

“Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient’s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This Condition is not met as evidenced by: Based on observation, record review and interview the agency failed to ensure comprehensive assessments were complete and accurate; the agency failed to ensure the comprehensive assessment accurately reflected the extent of patients’ limitations, disabilities and skilled needs and failed to ensure the Registered Nurse identified the immediate care and support needs of the patient and failed to ensure the comprehensive assessment was complete and accurate (see G0518), failed to ensure the comprehensive assessment incorporated a thorough review of patient’s medications, including high-risk medications (see G0536), failed to identify and make revisions or updates to the comprehensive assessment with changes in the patient’s condition (see G0544), failed to ensure patients were resumed within 48 hours after return home from a hospital admission (see G0548). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure patients received appropriate services which resulted in the agency not providing quality health care for all 54 patients. *”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on observation, record review, and interview, the Agency failed to ensure the care planning and coordination of services were provided as ordered by the physician, for 2 of 10 clinical records reviewed. (Patient #3 and #9). The cumulative effect of these systemic problems resulted in the home health agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation at 42 CFR 484.60 Care Planning, Coordination of Care, Quality of Care, with the likelihood to effect all 54 current patients receiving Home Health services from this provider. Findings include: 1. A revised April 2019 policy, titled ‘CARE/SERVICE COORDINATION Policy 4.067’ stated, “PURPOSE To ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services ... is the responsibility of each team member of the interdisciplinary group and will be appropriate to the needs and abilities of the patient, and relevant to the care/service provided. The clinician will be responsible for facilitating communications about changes in the patient’s status among the assigned personnel. F. Appropriate involvement of the patient and caregivers ... H. Proper communication upon “hand-off” of patient, including the opportunity for questions between the giver and receiver of patient information ... J. Coordination of care delivery to meet the patient’s needs, and involve the patient, representative, and caregivers, as appropriate, in the coordination of care activities ... 5. It will be the responsibility of the primary clinician to facilitate communication about changes in the patient’s status among all assigned disciplines. 6. Organization personnel will communicate changes in a timely manner via telephone, one- on-one meetings, case conferences, and home visits... 7. When the patient requires more than one (1) service from the organization, the Case Manager will be responsible for cooperative care planning in order to assure that goals, actions, and the interrelationship of services is not duplicated and to minimize the potential for missed or conflicting services 8. Written evidence of care coordination may be found in the plan of care/service, case conference summary forms, clinical notes in the patient’s clinical record ... “ 2. On 2-23-2024 at 9:30 AM during a home visit Patient #3 was found to be alone in their apartment. Memory deficits were apparent, patient asked similar questions multiple times. When queried as to whether the patient had their insulin yet today and how the patient receives their insulin, the patient reported that HHA 1 gave them their shots and reported this twice. A review of the clinical record for Patient #3 evidenced a primary diagnosis of Diabetes Mellitus (a disease affecting a person’s blood sugar levels), history of falling, digits amputated from right-dominant hand. The record failed to evidence and detail the extent of cognitive issues, recent vision correction surgery, and required frequent blood glucose monitoring with the administration of insulin up to 5x/day. The Plan of Care (POC) indicated Humalog, to inject 44 units every day as per sliding scale and Lantus 50 units two times per day both via Kwik Pen (a device a person uses to administer the insulin ordered when dialed to the prescribed dose). Further review evidenced an order dated 9-20-2023 from Person J with Doctor I’s office for Skilled Nursing to provide, “insulin administration/ medication management”. Plan of Care failed to evidence orders for Skilled Nursing, if and how often blood sugar levels were to be checked, a sliding scale for Humalog (insulin), patient-specific diabetic education, interventions, or measurable goal range. On 02-28-2024 at 11:34 AM, in an interview with Person J with the MD office indicated the MD’s ordered nursing services for insulin administration and diabetic management. Person J was unaware the patient was not receiving nursing visits to administer insulin and indicated the patient was to receive 25 Units of Lantus versus the 50 units that was on the plan of care/medication list. Person J indicated the patient was hospitalized on 01-12-2024. Hospital records were requested, received on 02-29-2024 at 1:04 PM from the hospital, and found the patient was in the Emergency Room (ER) on 01-12-2024 for a fall, blood sugar level of 468mg/dl, and cellulitis to the left lower extremity. Patient #3 was also discharged with antibiotics which the agency was not aware of. No Skilled Nursing visit was made after the ER visit. On 02-29-2024 at 9:50 AM, when presented with the document from Patient #3’s paper chart which evidenced an order from Doctor I’s office dated 09-20-2023 and stated, “… Referrals; Home Health Evaluate and treat … Clinical Indications/ Reason for Referral: insulin administration/ medication management …”, the Clinical Supervisor indicated she had not seen the order before. The Clinical Supervisor indicated she only obtained blood sugars during the recertification periods that are conducted approximately every 60 days. A review of the electronic chart evidenced a random blood sugar level reading obtained during the home health aide recertification visit:164mg/dl on 02-12-2024. Further record review revealed that the recertification assessment failed to include the patient’s history of serial blood sugar readings between visits. During a home visit on 03-01-2024 at 10:45 AM, Patient #3 called HHA 1 on their phone and notified them the surveyor was present. At 11:15 AM observed HHA #1 use their personal phone to scan the patient’s left upper arm to obtain their blood sugar results. HHA 1 reported the value (295) to the patient and asked them what dose of insulin (medication used to lower blood sugar) they would take. Patient #3 reported 20 units of Lantus insulin and 15 units of Humalog insulin. HHA 1 gathered the insulin from the fridge and handed the insulin to the patient. HHA 1 was queried about what they would do in the event the blood sugar was out of range. HHA 1 reported levels >400 would be called to the physician’s office. There was no documentation of calls to the agency or the Clinical Supervisor from HHA 1. The personnel record for HHA 1 failed to evidence any training or competency on the use of a glucometer or diabetic management including testing. On 02-26-2024 at 2:22 PM, the Administrator indicated HHA 1 cannot give insulin and cannot check blood sugars. On 02-27-2024 at 3:39 PM, the Clinical Supervisor indicated HHA 1 should not give insulin or check blood sugars and indicated this would be outside an aide’s scope of practice. Further indicated HHA 1 had not kept her abreast of patient’s appointments. On 02-29-2024 at 2:26 PM, the Clinical Supervisor indicated was unaware Patient #3 had a 5th digit amputated during their time on service with the agency, did not know eye surgery occurred, and did not know about the ER visit on 01-12-2024 for a fall. On 03-05-2024 at 12:52 PM, the Administrator and Clinical Supervisor reported that Patient #3 was sent back to the hospital on 03-05-2024 due to elevated blood sugars, cellulitis to his hand where it is noted to have missing digits and wounds to his left leg and heel where a partial amputation is noted. 3. Review of the clinical record for Patient #9 Plan of care dated 2/8/24 for the certification period of 02-10-2024 to 04-09-2024 indicated, “… patient and caregiver deny falls, injuries, ED visits or hospitalizations … 550 lbs … Home Health Aide to assist with personal cares and ADLS as indicated by limitations on functional and physical status impeding self–care. Patient is bedbound and totally dependent upon another person for all ADLS … Patient identified to be high risk for falls. SN to provide skilled assessment, identify and mitigate risk factors, provide instruction, reinforcement of teaching to prevent falls/injury. SN to instruct patient/caregiver on fall prevention as well and assess need for therapy services …” Section titled nursing indicated: “… Patient assessed to be at high risk for emergency department visits and/or hospitalization readmissions all necessary interventions to address the underlying risk factors are as follows:” And failed to identify and specify fall precautions. The record also evidenced an updated Plan of Care for 2-10-2024 to 4-09-2024, this Resumption of care dated 02-26-2024, indicated, “… Safety Precautions: Fall precautions, Support During Transfer and Ambulation … 2-20-24 was sitting on the side of bed, felt dizzy, syncope episode with fall, transported to ER, hospital admit DX Let Supracondylar Femur FX femur. Hospital D/C home on 2-25-24. Patient elected non-surgical tx of fx. Immobilizer in place on left leg in lieu of cast: non-pitting edema noted to left pedal …” The plan of care contained orders for: Skilled Nursing 3 times per week, Home Health Aide (HHA) 5 times per week “up to 8 hours per day” and Physical Therapy for evaluation. A review of the clinical record for Patient #9 evidenced the patient was hospitalized on 02-20-2024 for a fall with a fracture and returned home on 02-25-2024. Home Health services were resumed by RN 1 on 02-26-2024. Discharge paperwork from the hospital indicated Physical Therapy evaluation had been ordered. The record review failed to evidence any documentation of coordination with a Physical Therapist about the Resumption of Care order. A review of the Electronic Medical Record (EMR) on 03-04-2024 failed to evidence that a Physical Therapy visit had occurred. On 03-01-2024 at 1:40 PM, On 03-1-2024 at 1:40 PM in a telephone interview with Patient #9, indicated needed to get ahold of the agency, had been home from the hospital since Sunday 02-25-2024, and the physical therapist had not called or visited yet. Indicated had home health aides from 4 PM to 11 PM and overnight everyday except Saturday and Sunday. Indicated HHA #21 was the aide for Patient # 10 (who also resides in the home) and themselves, and that HHA #21 was always available as they resided in the same home as well. Patient #9 indicated had not had a daytime home health aide in more than 9 months and that HHA #21 was essentially doing double duty, caring for Patient #10 from 9 AM to 4 PM, for Patient #9 from 4 PM to 10 PM, and then covered Patient #9 overnight as well. On 03-04-2024 at 9:48 AM, Patient #9 indicated it was their understanding their surgeon had ordered Physical Therapy but still had not had a visit, nor received a phone call from a Physical Therapist. On 03-04-2024, a call was placed to Physical Therapist 1 but they failed to answer/ respond. 401 IAC 17-13-1(a)”

“Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA’s governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA’s performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to use measurable indicators to improve outcomes, patient safety, and quality of care (G 642); failed to use data derived from OASIS (Outcome and Assessment Information Set) assessments to monitor services and quality of care and failed to obtain governing body approval for the frequency and detail of data collection (G 644); failed to ensure the QAPI (Quality Assessment and Performance Improvement) program focused on high-risk, high-volume, or problem-prone areas (G 648); failed to document the agency had considered the incidence, prevalence, and severity of problems to select indicators and performance improvement efforts (G 650); failed to ensure performance improvement activities documented correction of identified problems related to the health and safety of patients (G 652) failed to ensure the agency tracked and analyzed adverse patient events and implemented actions to prevent adverse events (G 654); failed to measure and track performance improvement projects to determine if improvement occurred and was sustained (G 656); failed to ensure the QAPI Program included at least 1 performance improvement project, either in development or ongoing, that was based on the agency’s QAPI program activities and data obtained through tracking, measuring, and analyzing high-risk, high-volume, problem-prone areas (G 658); and failed to document governing body oversight of an ongoing program for quality improvement to include a requirement to identify and address possible fraud or waste (G 660), with the potential to affect all 54 active patients. The cumulative effect of these systemic problems resulted in the agency’s inability to ensure patients received appropriate services which could result in the agency not providing quality health care, thus resulting in non-compliance with Condition of Participation CFR 484.65 Quality Assessment/Performance Improvement. Findings include: 1. A review of an agency’s policy titled, ‘IMPROVING ORGANIZATIONAL PERFORMANCE’ Policy no. 5-001.1-.4 Revised April 2009 revealed “PURPOSE To establish patient outcomes as the primary focus of the organizations performance improvement activities. To improve organizational performance for focusing on high risk, high volume, and problem-prone areas. POLICY Senior management will have the responsibility: to guide the organization’s efforts in improving organizational performance; to define expectations of the performance improvement activities; and to generate the plan and processes the organization will utilize to assess, improve, and maintain quality of care and service. Performance improvement results will be utilized to address problem issues, improve the quality of care and patient safety, and will be incorporated into program planning and process design and modifications. All personnel will be active participants in the organization’s performance improvement activities. The Governing Body is responsible for ensuring that the performance improvement program is defined, implemented, and maintained, and is evaluated annually. PROCEDURE 1. Senior management will: A. Participate in educational activities … B. Set expectations for performance improvement and manage processes … C. Focus on high risk, high volume, and problem-prone areas … D. Adopt a structured framework … E. Identify and set specific outcomes for measurable improvement and acceptable limits for findings … F. Identify and participate in benchmarking activities that utilize: 1. Internal Standards … 2. Processes and Protocols … 3. Practice or service guidelines 4. Industry research or best practices G. Ensure that the organization adheres to the CMS Conditions of Participation for Quality Assessment and Performance Improvement (QAPI) standards H. Ensure that performance improvement projects are conducted that reflect the following standards: 1. The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the organization’s services and operations. 2. The organization must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. I. Allocate resources for performance improvement actives … J. Assure that each performance improvement activity contains the following elements: 1. Description of the indicator(s)/activities to be conducted 2. Frequency of activities 3. Designation of responsible party 4. Method(s) of data collection 5. Acceptable limits for findings 6. Who will receive the report 7. Follow-up plans if findings fail to meet acceptable limits including plan(s) of correction 2. Provide organization personnel training … 3. All other organization personnel will: A. Be involved in performance improvement … B. Promote communication and coordination of performance improvement activities as well as contribute to those activities. C. Forward relevant information regarding performance improvement activities to senior management and to the Performance Improvement Coordinator. D. Take action on recommendations generated through performance improvement activities as outlined in the organization’s written performance improvement plan. 4. Trends identified through performance improvement measurement and analysis will be reported to the Governing Body on a quarterly basis. 5. Results of performance improvement activities will be communicated with all staff … “ A review of an agency’s policy titled,’ ANNUAL ORGANIZATION EVALUATION ’ Policy no. 5-004.1-.3 Revised April 2009, revealed, “PURPOSE To provide a process for the annual overall evaluation of the organization … PROCEDURE 1. Within 45 days of the orgaization’s fiscal year end, the administrative personnel will prepare: A. Organization statistics, fiscal, and billing information B. Date collected from Patient Experience of Care Surveys C. Copies of organization policies and procedures for operations and patient care D. Summary information from the quarterly clinical/service record review … N. Quality Assessment Performance improvement findings … 2. The organization will be evaluated according to the following components … A. Organization and administration … B. Statistical/fiscal information … gross revenue by paer/service, revenue to expense analysis … direct and indirect expenses per discipline … C. Human Resource data … D. Clinical data … F. Quality assessment performance improvement activities … “ 2. A review of the QAPI binder revealed a QAPI/Governing Body meeting on 01/23/2023 at 4 PM with Person B, the former clinical manager along with the office manager which evidenced the Governing Body approved for the QAPI committee would meet monthly for the remainder of the year, with the Administrator to report quarterly meetings to the Governing Body. A QAPI/Governing Body meeting was held on 09/07/2023 at 8 AM, with Person B, the administrator, the office manager, and Person MM, the former human resource manager, which failed to evidence QAPI discussions. A QAPI/Governing Body meeting was held on 01/30/2024 at 4:15 with the administrator, administrative staff 2, the clinical manager, administrative staff 3, and the office manager, evidenced QAPI Policies were reviewed and approved by the Governing Body, the Governing Body agreed the QAPI committee would meet quarterly to ensure the QAPI program was followed and kept current, The QAPI committee was reorganized to include one member of each skilled discipline, and discussed tracking unwitnessed falls using Fall Root-Cause Analysis. Further review of the agency’s Quality Assurance Performance Improvement (QAPI) Binder failed to evidence the use measurable indicators to improve outcomes, patient safety, and quality of care, failed to monitor services and quality of care and failed to obtain governing body approval for the frequency and detail of data collection, failed to ensure performance improvement activities documented correction of identified problems related to the health and safety of patients, failed to ensure the agency tracked and analyzed adverse patient events and implemented actions to prevent adverse events, failed to measure and track performance improvement projects to determine if improvement occurred and was sustained, failed to ensure the QAPI Program included at least 1 performance improvement project, either in development or ongoing, that was based on the agency’s QAPI program activities and data obtained through tracking, measuring, and analyzing high-risk, high-volume, problem-prone areas, and failed to document governing body oversight of an ongoing program for quality improvement to include a requirement to identify and address possible fraud or waste and failed to evidence monthly meetings. 3. On 03/01/2024 at 10:44 AM the administrator indicated since Person B who is no longer employed, had overseen their QAPI program, it’s not getting done.”

“Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This Condition is not met as evidenced by: Based on record review and interview the Skilled Professional Nurse failed in their responsibility to ensure adequate provision of care for patients receiving Home Health services: the Skilled Professional Nurse failed to properly develop and evaluate the Plan of Care with the patient/caregiver/representative’s participation (see G0708), the Skilled Professional Nurse failed to be responsible for ensuring a timely Physical Therapy evaluation occurred after a hospital stay for a broken femur, after being home for nine (9) days (see G0710), agency failed to ensure caregiver education was conducted on special nutritional requirements and fluid restrictions (see G0714), the Skilled Professional Nurse failed to ensure verbal orders were obtained for the plan of care from the physician (see G0718). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure patients received appropriate services which resulted in the agency not providing quality health care for all 54 patients. *”

“Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to ensure the agency hired qualified home health aides and failed to ensure they were competent to carry out assigned patient care tasks (G754) failed to ensure the agency provided home health aide training which included classroom and supervised practical training which totaled 75 hours in a setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse (G760); failed to ensure a registered nurse conducted the classroom and supervised practical training (G780); failed to ensure home health aide assignments and duties were assigned by a registered nurse or other skilled professionals (G798); and failed to ensure home health aide provides services that are included in the plan of care, permitted to be performed under state law, and consistent with the home health aide training (800); and failed to ensure the HHA performed HHA duties for each patient as ordered in 1 of 2 home visits conducted (802). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure patients received appropriate services which could result in the agency not providing quality health care, thus resulting in non-compliance with Condition of Participation CFR 484.80 Home Health Aide Services Findings include: .”

“Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This Condition is not met as evidenced by: Based on record review and interview the agency failed to organize, manage, and administer its resources to achieve and maintain a high level of performance in the provision of Home Health care services to ensure patients could achieve pre-established goals and outcomes for their medical, nursing and rehabilitative needs: The Governing body failed to assume full legal authority and responsibility for managing and operating a Home Health Agency (see G0942), the agency failed to ensure an Alternate Administrator was in place (see G0954), the administrator failed to maintain responsibility and oversight of the agency’s day-to-day operations and instead relinquished responsibilities and duties to other unqualified individuals on an ongoing basis (see G0948), failed to ensure the Clinical Supervisor provided oversight of all patient care services and personnel (see G0958), failed to ensure the Clinical Supervisor was responsible for making personnel and patient assignments (see G0960). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure patients received appropriate services which resulted in the agency not providing quality health care for all 54 patients. * 410 IAC 17-12-1)(a)(1) 410 IAC 17-12-(a)(2)”

“Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This Condition is not met as evidenced by: Based on record review and interview the agency failed to ensure a faxed physician’s order had been integrated into the Electronic Medical Record (EMR) for over six (6) months (G1012), failed to ensure the contact information was accurate for the patient on the plan of care (G1018), failed to ensure the correct physician was listed on the plan of care (G1020), failed to ensure a discharge summary was sent to the ordering physician (G1022), and failed to ensure documentation submitted by employees was appropriately authenticated and dated (G1024). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure patients received appropriate services which resulted in the agency not providing quality health care for all 54 patients. Findings include: .”

“Completion of the comprehensive assessment CFR(s): 484.55(b) Standard: Completion of the comprehensive assessment. This Standard is not met as evidenced by: Based on observation, record review and interview the agency failed to ensure comprehensive assessments were complete and accurate: the agency failed to ensure the comprehensive assessment accurately reflected the extent of patients’ limitations, disabilities, and skilled needs, and failed to ensure the Registered Nurse identified the immediate care and support needs of the patient for 1 of 8 active clinical records reviewed. (Patient #3) Findings include: 1. Review of an agency document revised April 2019, titled ‘INITIAL AND COMPREHENSIVE ASSESSMENT Policy No. 4-018’ stated, “POLICY … The assessment will be patient-specific and comprehensive to include the patient’s need for home care, rehabilitative care, social, and discharge planning needs … 11. Ability to take medications … E. Patient’s medical and psychosocial history, including pertinent diagnosis and prognosis … The patient’s psychosocial/behavioral/neurological status, including emotional barriers to treatment, cognitive limitations, memory, role changes, family dynamics, coping mechanisms, reasoning/judgement and orientation ... G. The patient’s and family/caregiver’s educational needs, abilities, motivation, and readiness to learn … X. Specific, individualized patient needs and problems pertinent to the care being provided. Y. Past medical and surgical care including dates of onset/exacerbation. Z. Identification of responsible party and emergency contact(s) … 5. The comprehensive assessment shall reflect and determine: A. Patient problems/needs/strengths B. The patient’s continuing need for home care … H. The ability of the organization to adequately meet the patient’s medical, nursing, rehabilitation, social and discharge planning needs … 6. A plan of care will be developed from the information gathered during the initial and comprehensive assessment. The patient’s physician is consulted for approval if additions or modifications to the plan of care are required after the assessment is completed …” Review of an agency policy revised April 19, titled ‘ONGOING ASSESSMENTS Policy No. 4-019’ stated, “… POLICY The scope and intensity of ongoing assessments will be determined by the patient’s diagnoses, condition ... response to previous care, and the care setting. During each home visit the appropriate clinician will re-evaluate the patient according to the problems identified during the initial visit and thereafter … the clinician will reassess the patient for: … H. Mental status I. Functional status J. Safety/home environment K. Patient and family/caregiver support L. Progress toward goals and patient needs and problems M. Compliance to treatment and/or medications. 3 Re-assessments should focus on; A. Patient’s response to care B. Changes in patient condition C. Changes in patient diagnoses D. Changes in patient’s care environment or support systems … 7. The physician will be notified to verify any changes in medications ...” Review of an agency document revised April 2019, titled ‘REASSESSMENTS/RECERTIFICATION Policy No. 4-020’ stated, “POLICY … performed to measure patient progress towards outcomes … Any assessment findings that suggest a need to alter the plan of care will be reported to the patient’s physician … C. All communication shall be documented in the clinical record and the plan of care shall be updated and a verbal order sent to the physician, Documentation in the clinical record should support the assessment as well as the actions taken in response … 3. The update of the comprehensive assessment must, at a minimum, include: A. Completion of all follow-up dates items of OASIS and any changes in patient status B. Drug regimen review of all medications for drug interactions, potential adverse effects and drug reactions, duplicative drug therapy, ineffective drug therapy, significant side effects, significant drug interactions ... 10. The physician will be contacted to verify the continued need for care and his/her agreement with the continued plan of care …” 2. Review of the electronic clinical record for Patient #3 evidenced a Start of Care date of 06-20-2023 and a comprehensive assessment, dated 02-12-2024 for the certification period of 02-15-2024 through 4-14-2024, contained diagnoses which included, but were not limited to: Diabetes Mellitus (a disease in which your blood glucose, or blood sugar, levels are too high), Hemiplegia (a condition caused by brain damage or spinal cord injury which leads to paralysis on one side of the body, causing weakness, problems with muscle control, and muscle stiffness with degrees of symptoms varying) following cerebral infarction (ischemic stroke, occurs as a result of disrupted blood flow to the brain can cause parts of the brain to die off) affecting non-dominant left side, long term use of insulin, acquired absence of right leg below the knee, acquired absence of left toes, dependence on wheelchair, history of falling. The comprehensive assessment included a medication list which included but was not limited to: “HUMALOG (a fast-acting, mealtime insulin used to control high blood sugar in individuals with diabetes) KWIKPEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 44 units by subcutaneous route every day as per sliding scale subcutaneous (SQ)” and, “LANTUS (a long-acting insulin which starts to work about 2 hours after injection and lasts for up to 24 hours to maintain normal blood sugar levels) SOLOSTAR PEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 50 units subcutaneous route 2 times every day subcutaneous”, the record failed to evidence a sliding scale for the Humalog insulin. A section titled ‘Potential Risk for Infection Assessment, Assess for Confounding Factors’, “decreased cognition” was left unchecked. A section titled ‘Hospitalization Risk Assessment Tools and Emergency Preparedness’ where 16 of the 17 possible risk factors were marked as applicable, included but were not limited to: “… Polypharmacy (greater than 7 medications) … Noncompliance with medication regimen … Help with managing medications needed … ADL assistance needed … Home safety risks … History of falls … Low literacy level … Lives alone … Inadequate support network … > 1 hospitalization or ER visits in the past 12 months … Overall poor status/prognosis …” In the section titled Hospitalization risk the following box was marked, “Reported or observed history of difficulty complying with any medical instructions (for example, medications, diet, exercise) in the past 3 months”. The psychosocial section noted, “… Lack of caregiver/family support … Educational deficits/low literacy … Multiple co-morbidities …” However, “Community resources needed: … Community resources providing assistance: …” remained blank. “Caregiver Availability/Type of Assistance PATIENT LIVES ALONE IN [their] OWN APARTMENT”. The Sensory Assessment indicated, “no problems identified”. Mental/Cognitive Status indicated, “oriented x 3” and “forgetful”. Functional Status/Musculoskeletal indicated, “Amputation: Right BKA (below the knee amputation), left toes … Comments: Right BKA and left digits neuropathy, left Hemiplegia …” and failed to evidence amputation of fingers of the right dominant hand. “… Diabetic Management Option … Insulin: Insulin Administration LANTUS SOLOSTAR PEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 50 units subcutaneous route 2 times every day …” and failed to include ordered Humalog insulin. “… Insulin Administered By … Patient … Caregiver Availability: … No willing/able caregiver … Medication review: … Performed complete medication review and assessed drug interactions … Performed medication reconciliation due to noted discrepancies … Instructed patient/representative on medication administration and ensured patient is safe with medication administration until next visit …” The comprehensive assessment indicated the patient was to receive Skilled Nursing once every 30 days for supervisory visits and one (1) time every 56-60 days for Home Health Care Recertification, and Home Health Aide services five (5) times per week, “up to 8 hours per day” for safety with ADLS, IADLS, personal hygiene, grooming, medication reminders, light housekeeping, and meal prep. The comprehensive assessment failed to evidence the agency had identified the patient’s care needs required more than intermittent services, failed to detail how the patient’s specific functional impairments: poor manual dexterity related to the absence of fingers of the right dominant hand, extent of cognitive impairment, recent vision correction surgery, and lack of family/caregiver availability or support, collectively affected the patient’s ability to care for themselves and provide for their own needs, and failed to ensure regular and frequent Skilled Nursing visits were ordered to provide appropriate cares. Review of an outside document, dated 07-11-2023, titled ‘Office Visit’ indicated Patient #3 had visited with Doctor I, “… scheduled for finger amputations later this week …” Review of an outside document, dated 09-19-2023, titled ‘Medicare Preventive Annual Wellness Visit’ indicated Patient #3 had visited with Doctor I, “… Diabetic retinopathy … has appointment with ophthalmology next week … Has had amputations of multiple fingers of the right hand and the fifth is getting ready to amputated …” Review of an outside document, dated 11-20-2023, titled ‘Office Visit’ indicated Patient #3 had visited with Doctor I, “… scheduled for cataract surgery next month … Lantus Solostar U 100 insulin 100 units/ml (3ml) inject 25 units by subcutaneous route 2 times every day …” Review of an outside document, dated 01-19-2024, titled ‘Office Visit’ indicated Patient #3 had visited with Doctor I, “… Status post right bka (below the knee amputation) cannot do a foot exam on the left … does have some left lower extremity edema … had cataract excisions (surgery to remove clouded lens from the eye) 12/23 and 1/14 … Start date 12/11/23 Humalog KwikPen (U 100) insulin 100units/ml subcutaneous inject TID (three times daily) per insulin protocol, max dose 44 units … Start Date 12/26/23 Lantus Solostar U-100 insulin 100 units/ml 3ml subcutaneous pen inject 25 units by subcutaneous route two times every day … Emergency Room, leg infection/weakness, 1/12/24 … Fall Risk Plan: The patient has fallen 4 times in the past year …” Review of an outside document, dated 01-12-2024, titled ‘ED (Emergency Department) Provider Notes’ stated, “… Chief complaint: Patient presents with fall, weakness generalized … Glucose Random: 468mg/dl … Past Medical History: Diagnoses … dementia … Final Diagnosis: Cellulitis, left lower extremity, weakness, generalized … Discharge Condition: Stable … Medication changes: Clindamycin HCL 300 mg oral three times daily …” 3. On 02-29-2024 at 2:26 PM, in an interview, the Clinical Supervisor was unaware Patient #3 had an amputation of the right fifth digit during his time under the agency’s care, was unaware the patient had undergone vision correction surgery, and was unaware of the patient’s recent Emergency Room visit on 01-12-2024 for a fall, cellulitis of the left lower leg, elevated blood sugar of 468mg/dl, and was unaware the patient had been sent home with antibiotics. On 03-05-2024 at 12:08 PM the Administrator, after reviewing the record for Patient #3, indicated was, “not sure why nursing wasn’t ordered” initially for the patient. On 03-04-2024 at 10:21 AM, the Administrator indicated had visited Patient #3. Indicated patient needed nursing visits, patient was confused, needed assistance with transfers, needed help with insulin, agreed had many needs. On 03-05-2024 at 1:16 PM, the Administrator indicated that if the agency recognized a patient required 24-hour care, “maybe they need a skilled facility”.”

“Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status, but not less frequently than- This Standard is not met as evidenced by: Based on observation, record review, and interview the agency failed to identify and make revisions or updates to the comprehensive assessment with changes in the patient’s condition for 1 of 8 active clinical records reviewed. (Patient #3) Findings include: 1. Review of an agency document revised April 2019, titled ‘MONITORING PATIENT’S RESPONSE/REPORTING TO PHYSICIAN Policy No, 4-012’ stated, “PURPOSE To provide guidelines … for reporting to the patient’s physician … PROCEDURE … 3. The patient’s physician will be contacted to same day when any of the following occur: A. Significant changes in the patient’s condition … E. Changes that have occurred regarding diagnosis, prognosis, or treatment (including procedures, medications, and limitations) … 4. All conferences or attempts to communicate with the physician will be documented in the clinical record …” 2. Review of an outside document, dated 01-12-2024, titled ‘ED (Emergency Department) Provider Notes’ stated, “… Arrived 13:19 (1:19 PM) … Chief complaint: Patient presents with fall, weakness generalized … Glucose Random: 468mg/dl … Past Medical History: Diagnoses … dementia … Final Diagnosis: Cellulitis, left lower extremity, weakness, generalized … Discharge Condition: Stable … Medication changes: Clindamycin HCL 300 mg oral three times daily … Discharged 19:17 (7:17 PM) …” The hospital note also detailed the return trip home via ambulance, which was documented to have occurred from 19:17 (7:17 PM) to 19:45 (7:45 PM). 3. Review of the clinical record for Patient #3 failed to evidence documentation of patient’s Emergency Room Visit on 01-12-2024 related to a fall, cellulitis of the left leg, and elevated blood sugars of 468mg/dl and failed to evidence updates had been made to the record. The record did however evidence HHA #2’s completed home health aide visit note for 01-12-2024 from 8:12 AM to 7:22 PM. Additionally, on 1-12-2024, HHA #1 serviced the patient from 4:15 PM to 12:00 AM, for Entity U, the agency’s sister company, a personal services agency. The aide notes failed to evidence the patient‘s Emergency Room visit, and failed to evidence documented communication with RN to report same. 4. On 02-28-2024 at 11:34 AM, in a telephone interview regarding Patient #3 with Person J, indicated they were aware the patient had an emergency room visit on 1-12-2024 because they could see the patient’s home from the office and witnessed the day the ambulance was there, not because the home health agency had informed them. Indicated had not received any telephone communication from A Passionate Helping Hand since March of 2023. On 02-29-2024 at 2:26 PM, in an interview, the Clinical Supervisor was unaware of Patient #3’s recent Emergency Room visit on 01-12-2024 for a fall, cellulitis of the left lower leg, elevated blood sugar of 468mg/dl, and was unaware the patient had been sent home with antibiotics. Indicated the aide does not report anything. 410IAC 17-14-1(a)(1)(B)”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on record review, and interview the agency failed to ensure the patient received an individualized plan of care that identified and addressed the care and services necessary to meet patient-specific needs, failed to ensure patient-specific outcomes could be measured or achieved by failing to ensure regular and frequent skilled nursing services were provided to the patient, failed to allow periodic review of the plan by the physician by failing to obtain verbal orders and/or signature of ordering physician to continue home health services, in 2 of 8 active clinical records reviewed. (Patients #3 and #8) Findings include: 4. A review of the clinical record for Patient #8 revealed a Home Health Certification and Plan of Care document for the certification period of 01/25/2024 – 03/24/2024 which evidenced diagnoses but not limited to Type 2 diabetes mellitus (a long-term condition in which the body has trouble controlling blood sugar and using it for energy) with diabetic chronic kidney disease (a decrease in kidney function that occurs in some people who have diabetes which means that your kidneys are not doing their job as well as they once did to remove waste products and excess fluid from your body and these wastes can build up in your body and cause damage to other organs) and end-stage renal disease (a person’s kidneys cease to function permanently leading to the need for regular course of long-term dialysis [the process of removing excess water, solutes, and toxins from the blood in people whose kidneys can no longer perform these functions naturally] or a kidney transplant), and legal blindness, as defined in USA. Mental/Cognitive Status Oriented x 3, Forgetful Caregiver Status: Patient is blind, lives in residential home and has 24 hours supervision, makes own decisions. Psychosocial Status: Barriers to Heath Status (Multiple co-morbidities, Multiple health providers, Other (Blind) Comments: The patient is legally blind and requires max assistance of another person for safety to prevent falls. Patient #8 nutrition requirements were Hearth Healthy, No concentrated sweets, fluid restriction (1 liter per day), and renal diet. Patient #8 medications included but were not limited to Insulin Glargine (a synthetic version of human insulin) 100 units/milliliter subcutaneous (applied under the skin) solution 60 milliliters inject 15 units subcutaneously daily, Lantus Solostar Pen ( Lantus contains the drug insulin glargine, 3-mL prefilled SoloStar pen that contains 100 units of insulin per milliliter used manage blood sugar levels with just one dose a day and delivers the precise dose you dial time after time. People who are blind or have vision problems should not use the Lantus SoloStar prefilled pen without help from a person trained in its use )100 units/milliliter subcutaneous solution inject 20 units by subcutaneous route 1 time daily at bedtime, intramuscular (IM) (administered into a muscle), and Novolog Flexpen(Rapid-Acting Insulin is mealtime insulin made to help control blood sugar spikes) (directions: look at the window to make sure the liquid is clear and has no color or specks. Do not use the pen if it is not clear, has a color or you can see specks in it. It is normal to see air bubbles, turn the knob on the pen to a dose of 2 units, hold the pen with the needle straight up, tap the side of the pen to get rid of any air bubbles, and push the injection button until you see 0 in the dose window. You should see a drop or stream of liquid at the end of the needle. This means your pen is ready to use, check the dose window to make sure it shows 0, and turn the knob on the end of the pen to find your dose. The pen will make a click for each unit of insulin)100 units/milliliter subcutaneous solution Inject 8 units by subcutaneous route 3 times daily with meals intramuscular (IM). Patient #8 was to receive SN (skilled nursing) 1 time a month for 2 months, PT (Physical Therapy) 2 times a week for 9 weeks, and HHA (home health aides) 7 times a week for 9 weeks. The Home Health Certification and Plan of Care failed to evidence correct routes for medications and duration of home health aide visits. 5. On 03/01/2024 at 2:10 PM, Patient #8 indicated they give their insulin, the home health aides hand the pre-prepared insulin to them, and they inject themselves. When this writer queried what kind and how much insulin they take, Patient #8 replied, “I know what medicine I take, I take only 5 units of insulin at night”. Patient #8 further indicated the HHA’s cook anything I want to eat and drink. On 03/04/2024 at 1:37 PM, the clinical manager indicated they weren’t sure how the insulin is managed, but thought Patient #8 gave their own injections and would have to check on the types of insulin, route, and dosage, Patient #8 did require 24-hour supervision and Patient #8 never complained when there is no staff, and further indicated that no special diet teaching had been done with the home health aides. On 03/05/2024 at 9:36 AM, HHA 24 indicated they staff overnights and Patient #8 mostly sleeps during the night but indicated they fix snacks for Patient #8 on occasion when requested, and when queried if they knew the patient was on a special diet or fluid restriction they replied no, and further indicated they didn’t have training on types of food Patient #8 should be eating or how much fluid Patient #8 should have. On 03/06/2024 at 8:23 am, Person J, a community health liaison Registered Nurse (RN) at Entity 8 returned a phone call and indicated they were meeting with Person T, physician for Patient #8 later in the morning. When this writer expressed concerns about Patient #8 insulin administration, Person J indicated they would fax the history and physical, medication list, and last hospital admission to this writer for clarification. On 03/06/2024 at 3:26 PM, Person J called this writer, indicating they weren’t comfortable faxing the patient’s health information. This writer indicated they would send the release of protected health information to them, Person J gave this writer their email address, then indicated Patient #8 is refusing Person J to release their health information to anyone. This writer sent the PHI letter to Person J on 03/26/2024 at 3:32. This writer did not receive the patient’s history and physical, medication profile, and hospital admission. 410 IAC 17-13-1(a) 1. Review of an agency document, revised April 2019, titled ‘CARE PLANNING PROCESS Policy No. 4-001’ stated, “… POLICY ... The individualized plan of care includes: ... L. Nutritional requirements … 3. Based on the assessment and conclusions, the plan of care will include but not be limited to: A. Patient specific interventions and education B. Identified patient problems and needs, including functional limitations activities permitted, nutritional requirements C. Reasonable, measurable, and individualized goals and outcomes identified by the organization and the patient D. Specific services and treatments to be provided E. Actions to be taken to meet the patient goals F. Type, frequency, and duration of above actions ... J. The patient’s mental, psychosocial and cognitive status K. All medications L. Safety measures to protect against injury M. A description of patient risk for emergency department visits and hospitalization readmission and all necessary interventions to address all underlying risk factors ... 10. Clinicians will inform the patient’s physician of any changes that suggest a need to alter the plan of care ... 12. problems and/or needs related to patient’s condition … patient family/caregiver support systems, and relevant medication monitoring will be included in the plan of care ...” Review of an agency document, revised April 2019, titled ‘PHYSICIAN PARTICIPATION IN PLAN OF CARE Policy No. 4-002’ stated, “PURPOSE To provide guidelines for the physician’s participation in home health care services POLICY … The attending physician will participate in the care planning process by initiating, reviewing and revising the plan of care … Definition: Verbal order: A physician order that is spoken to appropriate personnel and later put in writing for the purposes of documenting as well as establishing or revising the patient’s plan of care … PROCEDURE Physician … orders will be individualized … 2. When services are provided on the basis of a physician’s verbal orders, a registered nurse … shall document the orders in the patient’s clinical record, and sign, date, and time the orders … Orders are reviewed for appropriateness and accuracy before care, treatment, and services are provided …” Review of an agency document, revised April 2019, titled ‘VERIFICATION OF PHYSICIAN ORDERS Policy No. 4-003’ stated, “POLICY Orders will be obtained from a licensed physician ... for care and services to be provided to home health patients … 8. Signed orders will be in the clinical record within 30 days of initiation of care or interim order, unless otherwise specified by applicable state law and regulation …” 2. On 2-20-2024 at 9:00 AM during a home visit with Patient # 3, the patient was found to be alone in their apartment. Memory deficits were apparent, patient asked similar questions multiple times (i.e. “Would you like a drink?”, “Do you live around here?”, “Would you like a seat?”), despite having been answered moments previously. The patient presented with a right below-the-knee amputation and left toes were amputated, fingers to the right hand had been amputated. Indicated was learning to use their left hand to write their signature. Was able to hold cell phone with the right hand. The patient transferred themselves from their bed to their electric wheelchair. When queried as to whether the patient had their insulin yet today and how the patient receives their insulin, indicated “[Home Health Aide {HHA} #1] will give me my shots”, and indicated this twice. Review of the electronic clinical record for Patient #3 evidenced a Plan of Care dated 02-12-2024 for the certification period of 02-15-2024 through 4-14-2024 and contained diagnoses which included, but were not limited to: Diabetes Mellitus (blood glucose, or blood sugar, levels are too high), Hemiplegia (brain damage or spinal cord injury that leads to paralysis on one side of the body, causing weakness, problems with muscle control, and muscle stiffness with degrees of symptoms varying) following cerebral infarction (ischemic stroke, a result of disrupted blood flow to the brain which can cause parts of the brain to die off) affecting non-dominant left side, long term use of insulin, acquired absence of right leg below the knee, acquired absence of left toes, dependence on wheelchair, history of falling. The plan of care contained a medication list which included but was not limited to: “HUMALOG (a fast-acting, mealtime insulin used to control high blood sugar in individuals with diabetes) KWIKPEN 100 UNITS/ML SUBCUTANEOUS (intended for injection given in the fatty tissue, just under the skin) SOLUTION 30 Inject 44 units by subcutaneous route every day as per sliding scale (varies the dose of insulin based on blood glucose level, the higher your blood glucose the more insulin you take, this method is more precise than fixed dose insulin) subcutaneous (SQ)” and, “LANTUS (a long-acting insulin that starts to work about 2 hours after injection and lasts for up to 24 hours to maintain normal blood sugar levels) SOLOSTAR PEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 50 units subcutaneous route 2 times every day subcutaneous”, the record failed to evidence a sliding scale. The plan of care ordered Skilled Nursing every 30 days for supervisory visits and one (1) time every 56-60 days for Home Health Care Recertification, and ordered Home Health Aide services 5 times per week, “up to 8 hours per day” for safety with ADLS, IADLS, personal hygiene, grooming, medication reminders, light housekeeping, and meal prep. The 60-day summary indicated, “… Denies fall, injury, ED visits or hospitalizations or medication concerns this home health episode … plan of care reviewed with patient, patient in agreement with plan and denies any need for changes at this time …” A section titled ‘Nursing’ contained the following nursing interventions, “… Patient assessed to be at high risk for emergency department visit and/or hospital readmission. All necessary interventions to address the underlying risk factors are as follows: SN to minimize/eliminate risk for hospitalization due to problems associated with physical limitations … SN to assess and instruct patient on mitigation of hospital risks: due to problems associated with: polypharmacy/high risk medications: DM, PVD, physical limitations: poor health literacy and patient support …” and failed to evidence patient-specific details. A section titled ‘Risk Factors’ stated, “… SN to assess diabetic status, identify any signs or symptoms of impaired diabetic function, report significant changes to physician … SN to instruct on self-management program to include, disease process, who to contact if signs and symptoms persist or worsen as well as dietary measures, medication management, foot care precautions, blood sugar monitoring, hypo/hyperglycemia management and long term complications … SN to prepare/teach patient/caregiver to administer insulin [dosage and frequency] using aseptic technique … SN to perform medication review each skilled nursing visit and reconcile medications as indicated. SN to instruct on all new and changed medications and reinforce teaching related to use of medications a part of disease process or demonstrated knowledge deficit …” A section titled, ‘Goals’ stated, “… Patient will demonstrate compliance with medication regimen as evidenced by correct administration, reporting side effects or adverse reactions by EOE (end of episode). Patient [sic]demonstrate ability to effectively manage medication regimen by EOE … Patient will demonstrate competence with self-management of DM [Diabetes Mellitus] as evidenced by adherence to the medication regimen, ability to identify s/s necessitating contact with medical professionals, diet regimen guidelines, activity compliance and symptom management by EOE …” The plan of care failed to evidence how the patient’s specific functional impairments: extent of cognitive deficits, poor manual dexterity related to the patient’s absence of fingers of the right hand, recent vision correction surgery, and lack of family/caregiver availability or support, collectively affected the patient’s ability to care for themselves and provide for their own needs. The plan of care failed to evidence whether the patient’s understanding of diabetic management had been assessed and was appropriate, failed to evidence serial blood glucose readings had been or would be tracked/monitored, failed to evidence physician-directed patient-specific blood glucose parameters, failed to evidence return-demonstrations had been performed and the patient was found to be proficient in self-monitoring of blood glucose levels, accurate calculation of insulin dosing based on a sliding scale, and self-administration of injectables. The plan of care failed to evidence the nurse had identified the patient’s specific skilled nursing needs, failed to address those needs by failing to secure orders from the physician for additional skilled nursing visits to provide skilled monitoring, education/teaching, and interventions as outlined in the plan of care, and by extension failed to measure or make any progress toward the goals indicated. Review of the paper clinical record for Patient #3 evidenced an order from Doctor I’s office dated 09-20-2023 which stated, “… Referrals; Home Health Evaluate and treat … Clinical Indications/Reason for Referral: insulin administration/medication management …” Review of an outside hospital document dated 01-12-2024, detailed Patient #3’s visit to the Emergency Room related to a fall, elevated Blood Sugar reading of 468 mg/dl, general weakness, and cellulitis of the left lower extremity. The document also evidenced a diagnosis of dementia, and the patient had been released home with oral antibiotics. 3. On 02-28-2024 at 11:34 AM, in a telephone interview regarding Patient #3 with Person JJ, of Doctor I’s office, indicated the intent of home health services was for home care to provide insulin administration and management. Was unaware patient was not receiving these services. Indicate the patient had “cognitive deficits for sure”, indicated was always accompanied by HHA #1, and was not aware HHA #1 was an employee of the Home Health Agency and not a private caregiver. Indicated HHA #1 has put themselves on the patient’s list of contacts to release information to. Indicated had been aware the patient was hospitalized on 1-12-2024 because they could see the patient’s home from the office and saw the day the ambulance was there, not because the agency informed them of the Emergency Room visit. Indicated had not received any telephone communication from A Passionate Helping Hand since March of 2023, specifically no requests for verbal orders. Indicated however that HHA #1 had placed several calls to the physician’s office: asked for refills of medications, requested the patient’s medication list, requested a sliding scale for insulin, asked for a referral to A Passionate Helping Hand, asked for a lift chair, requested a pain management referral, asked for a different pain management referral when the first did not accept the patient’s insurance, asked for a sleep study, called when the patient’s Amitriptyline was not working, requested a prescription for TED hose, asked for new Dexcom CGM (continuous glucose monitor). Person J reviewed the two insulin orders and indicated the Humalog order was not accurate, and would check into this further, as ‘44 units’ and a ‘sliding scale’ were both mentioned. Indicated the Lantus order should not be 50 units, but rather 25 units, but would clarify this further. Expressed concern that if the patient were truly taking 50 units of Lantus twice daily, this was too much medication, and the patient would run out of medication too soon and insurance may not cover this. Indicated no one from the agency had called to request the patient’s medication list and no requests had been made for copies of recent office visit notes. On 02-28-2024 at 4:00 PM, the Clinical Supervisor was made aware of the discrepancies with Patient #3’s insulin orders, she indicated she had spoken with Doctor I’s medical assistant today to request new orders and reconcile medications and was waiting for a reply back. When queried as to whom she usually speaks to at Doctor I’s office and when the last call would have been, indicated could not remember. On 02-29-2024 at 9:50 AM, in an interview with the Clinical Supervisor, indicated had not ever seen the paper document with the physician’s order for nursing to provide insulin administration and medication management and was surprised to learn the agency had this document in their possession since September of 2023. On 02-29-2024 at 2:26 PM, in an interview with the Clinical Supervisor, was unaware that Patient #3 had an amputation of the right fifth digit during his time under the agency’s care, was unaware the patient had undergone a vision correction surgery, and was unaware of the patient’s recent fall that led to an ER visit on 01-12-2024, with an elevated blood sugar reading of 468mg/dl, and cellulitis of the left lower leg and the patient had been sent home with antibiotics, indicated aide does not relay information to her. On 03-05-2024 at 12:52 PM, the Administrator and Clinical Supervisor indicated HHA #1 and #2 had called to inform that Patient #3 had just been hospitalized with an infection to the left hand, elevated blood sugars, and ulcers to the left leg and left heel, and believed this to be due to the way the patient’s leg rests on the prosthetic. On 03-05-2024 at 1:16 PM, the Administrator indicated that if the agency recognized a patient requires 24-hour care, “maybe they need a skilled facility”.”

“Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This Standard is not met as evidenced by: Based on record review and interview the agency failed to conform with physician orders they had received, and delayed patient care by nine (9) days, in 1 of 8 active records reviewed. (Patient #9) Findings include: 1. Review of a document, revised April 20192, titled ‘CARE/SERVICE COORDINATION Policy 4.067’ stated, “PURPOSE To ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services PROCEDURE ... H. Proper communication upon “hand-off” of patient, including the opportunity for questions between the giver and receiver of patient information ... 5. It will be the responsibility of the primary clinician to facilitate communication about changes in the patient’s status among all assigned disciplines. 6. Organization personnel will communicate changes in a timely manner via telephone, one-on-one meetings, case conferences, and home visits. Documentation of all communications will be included in the clinical record on a communication note, case conference summary, or clinical note. Documentation will include: the date and time of the communication, individuals involved with the communication, information discussed, and the outcome of the communication. 7. When the patient requires more than one (1) service from the organization, the Case Manager will be responsible for cooperative care planning in order to assure that goals, actions, and the interrelationship of services is not duplicated and to minimize the potential for missed or conflicting services ...” Review of an agency document, revised April 2019, titled ‘CARE PLANNING PROCESS Policy No. 4-001’ stated, “PURPOSE To provide direction to the clinicians providing direct patient care ... POLICY ... The care planning process will be documented in the plan of care … clinical notes … care conference/summary forms, and discharge/clinical summaries ... 1. Individualized plan of care: The patient-specific clinical plan of care includes: ... D. All patient care orders ...” 2. Review of the clinical record for Patient #9 with a start of care of 12-17-2022 evidenced an updated plan of care, dated 02-26-2024 and contained diagnoses which included but were not limited to: Chronic kidney disease, stage 3 unspecified (kidneys have mild to moderate damage, and they are less able to filter waste and fluid out of the blood, this waste can build up in the body and begin to harm other areas), morbid obesity (being more than 100 pounds over your ideal weight), displaced supracondylar fracture without intracondylar extension of lower end of left femur, initial (closed fracture of the femur, or the ‘thigh bone’). The Plan of Care also indicated the patient was ‘bedbound’ and ‘required total care from another person’. Skilled nursing was ordered for 3 times per week for 6 weeks, then 1 time per week for 1 week. Home Health Aide was ordered for 5 times per week for 6 weeks, then 2 times per week for 1 week. Skilled Physical Therapy was ordered for, “1xEval” indicating an evaluation visit. The record indicated patient had returned home on 02-25-2024 after a recent hospital stay and home health services had been resumed by RN 1 on 02-26-2024. The plan of care stated, “02-20-2024 patient was sitting on the side of the bed, felt dizzy, syncope episode with fall, transported to ER (Emergency Room), hospital admit DX(diagnosis) Left Supracondylar FX(fracture) Femur ... patient elected nonsurgical tx(treatment) of fracture. Immobilizer in place on left leg in lieu of cast ...” Record review failed to evidence documentation of coordination with a Physical Therapist about the Resumption of Care order. Review of the Electronic Medical Record (EMR) on 03-04-2024 failed to evidence a Physical Therapy visit had occurred. Review of a third-party document dated 02-25-2024, from Entity KK, an acute care hospital, titled ‘DISCHARGE SUMMARY: FINAL REPORT’ stated, “… Discharge Orders/Instructions … Home Health Therapy Services … PT(Physical Therapy) General Assessment/Home Safety Eval … Orthopedic Trauma Discharge Instructions … Activity Restrictions & Range of Motion: Weight Bearing to your Left Lower Extremity … Range of Motion: no restrictions … Ice and elevate to help control pain and swelling …” 3. On 03-01-2024 at 1:40 PM in a telephone interview with Patient #9, indicated needed to get ahold of the agency, had been home from the hospital since Sunday 02-25-2024, and the physical therapist had not called or visited yet. On 03-04-2024 at 9:24 PM, RN 1 indicated was aware Patient #9 was needing Physical Therapy and was aware Physical Therapy had not been out to see the patient yet. When queried as to who would make sure Physical Therapy goes out to see the patient, indicated either the office manager or they, themselves would. On 03-04-2024 at 9:48 AM, Patient #9 indicated it was their understanding the Orthopedist had ordered Physical Therapy but still had not had a visit, nor received a phone call from a Physical Therapist. On 03-04-2024 at 11:45 AM, when queried as to whether the agency had notified them Patient #9 had been hospitalized recently, indicated they only found out because the hospital pharmacist had contacted them, not because the home health agency had notified them. On 03-04-2024, a call was placed to Physical Therapist 1 but they failed to answer/respond back. On 03-05-2024 at 9:30 AM, the office manager indicated she knew that Patient #9 needed Physical Therapy, and had just received orders yesterday. After updating the office manager, she indicated she did not know the orders were written on the hospital discharge paperwork. On 03-05-2024 at 3:55 PM, the Administrator indicated RN1 was making arrangements to ensure the Physical Therapist would get out to visit Patient #9 today. And indicated the responsible party was supposed to be RN 1, but RN 1 probably did not know that.”

“Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA’s governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This Standard is not met as evidenced by: Based on record review and interview the agency failed to ensure the governing body had oversight of an ongoing program for quality improvement to include a requirement to identify and address possible fraud or waste for 1 of 1 agency. Findings include: 1. Review of an agency’s policy titled,’ BILLING AND COLLECTIONS’ Policy No. 3-009.1-.4 Revised April 2009 revealed, “ … Other procedures Regarding Billing 1. Bill only for items or services actually rendered … 4. Check to ensure that there is no duplicate billing … “ A review of an agency document revised April 2019 ‘GOVERNING BODY Policy No. 1-002’ stated, “... A. Relevant findings of performance improvement activities are consistently provided to the Governing Body to allow for oversight of the quality assessment and performance improvement (QAPI) program. The governing body will ensure the following: ... That any findings of fraud or waste are appropriately addressed ...” 2. A review of the clinical record for Patient #4 evidenced a HHA visit conducted by HHA 1 on 02/23/2024 from 7:53 PM to 8:51 PM. A review of the clinical record for Patient #3 with Entity U, an attendant care service agency (ATTC) evidenced an ATTC visit conducted by HHA 1 on 02/23/2024from 4:15 PM to 12 AM, with a clock-out time of 4:27 PM. The agency failed to ensure there was no duplication of services. 3. A review of the clinical record for Patient #4 revealed a home health aide visit conducted by HHA 19 on 02/20/2024 from 2:30 PM to 3:30 PM, and a home health aide visit was conducted by HHA 19 on 02/23/2024 from 7:53 PM to 8:51 PM. 4. On 02/26/2024 at 4 PM, the office manager provided a document titled, ‘Patient Visits Verification Log’ for Patient #4 which revealed a home health aide visit on 02/20/2023 for 11.53 hours and on 02/23/2024 for 58 minutes. The billing report of Patient #4 for the week of 02/19/2024 - 02/23/2024 revealed on 02/20/2024 8 units were billed for $228.16 when the HHA was clocked in for 1 hour. On 02/23/2024 8 units were billed for $228.16 when the home health aide was clocked in for 58 minutes. Further review of home health aide visits conducted by HHA visits versus billed for Patient #4 were the following but not limited to: 11/20/2023 9 hours 16 minutes worked, 11 hours billed; 11/24/23 9 hours 14 minutes worked, 11 hours billed, 12/25/24 hours work 4.53 hours, 8 hours billed. 5. A review of the clinical record for Patient #5 revealed a Home Health Certification and Plan of Care document for the certification period of 02/11/2024 – 04/10/2024 which Patient #5 was to receive home health aide services (HHA) 5 times a week for 9 weeks 8 hours daily. On 02/26/2024 at 9:50 AM, the administrator indicated Patient #5 received services from Entity U, providing attendant care services (ATTC). Review of services provided from Entity U and the agency for the certification period of 02/11/2024 – 04/10/2024 evidenced the following: 02/12/2024 services provided were HHA services from 7:25 AM to 3:25 PM and ATTC services from 7 AM to 3 PM; 02/13/2024 services provided were HHA services from 7:39 AM to 3:44 PM and ATTC services from 7 AM to 3 PM; 02/14/2024 services provided were HHA services from 7:24 AM to 3:24 PM and ATTC services from 7 AM to 3 PM; 02/15/2024 services provided were HHA services from 7:30 AM to 3:30 PM and ATTC services from 7 AM to 3 PM; 02/16/2024 services provided were HHA services from 7:22 AM to 3:28 PM and ATTC services from 7 AM to 3 PM; 02/19/2024 services provided were HHA services from 7:27 AM to 3:35 PM and ATTC services from 7 AM to 3 PM; 02/20/2024 services provided were HHA services from 7:27 AM to 3:27 PM and ATTC services from 7 AM to 3 PM; 02/21/2024 services provided were HHA services from 7:23 AM to 3:34 PM and ATTC services from 7 AM to 3 PM; 02/22/2024 services provided were HHA services from 7:30 AM to 3:30 PM and ATTC services from 7 AM to 3 PM; 02/23/2024 services provided were HHA services from 7:23 AM to 3:24 PM and ATTC services from 7 AM to 3 PM; 02/26/2024 services provided were HHA services from 6:57 AM to 3 PM and ATTC services from 7 AM to 3 PM. The agency failed to ensure there was no duplication of services. 6. A review of the clinical record for Patient #6 revealed a Home Health Certification and Plan of Care document for the certification period of 02/03/2024 – 04/02/2024 which evidenced diagnoses but not limited to Type 2 diabetes mellitus (a long-term condition in which the body has trouble controlling blood sugar and using it for energy). Mental/Cognitive Status Oriented x 3, Depressed. Patient #6 was to receive HHA (home health services) 5 times a week for 9 weeks up to 8 hours a day. A review of the clinical record for Patient #6 indicated a nursing supervisory visit was conducted on 02/06/2024 by RN 1 at 4:15 PM. RN 1 indicated on the document that the HHA was not present. There was a HHA visit note documented by HHA 19 dated 02/06/2024 with a clock in time of 3:58 PM and a clock out time of 12 AM. On 02/26/2024 at 11 AM, Patient #6 indicated they do not receive any services in the evening, the only service they receive is from 8 AM to 4 PM, Monday through Friday, then asked this writer if they were eligible for evening hours which this writer indicated they needed to speak with the agency. On 02/26/2024 at 11:49 AM, when queried about the supervisory visit for Patient #6, conducted on 02/06/2024, RN 1 indicated that if they marked on the supervisory visit that an HHA wasn’t present, then they weren’t present. When queried if Patient #6 was receiving services from another agency, they stated, “I’m not aware of any other company, as far as I know, Patient #6 isn’t receiving any other services”. On 02/28/2024 at 4:32 PM, this writer called to see if a home visit could be conducted with Patient #6, with Patient #6 declining. This writer asked if a home health aide was there, and they indicated they were alone. 7. On 02/23/2024 at 12:54 PM the office manager indicated they can go into the electronic medical record, clock home health aides in and out, and “manually adjust their times to reflect the time the aides are to be there”. When queried if they were capable of making up a visit to reflect a visit was completed when it wasn’t, the office manager indicated that could be done but we don’t do that. 8. On 02/28/2024 at 3:56 the administrator wanted to know who Patient #6 was, raised their voice at this writer, and indicated they should get an attorney since this writer wouldn’t disclose who the patient was. On 3/04/2024 at 3:55 PM, the administrator indicated the employees knew they couldn’t do this, this would be fraud, and stated, “I don’t know how this had happened and I don’t know what is going on”. 9. Review of the clinical record for Patient #3 evidenced HHA #2’s completed home health aide visit note for 01-12-2024 from 8:12 AM to 7:22 PM. Additionally, on 1-12-2024, a completed “CUSTOM ATTC (Attendant Care) WAIVER NOTE’ indicated HHA #1 serviced the patient from 4:15 PM to 12:00 AM, for Entity U, the agency’s sister company, an attendant care agency. Review of an outside document, dated 01-12-2024, titled ‘ED (Emergency Department) Provider Notes’ evidenced an Emergency Room visit for Patient #3 and stated, “… Arrived 13:19 (1:19 PM) … Discharged 19:17 (7:17 PM) …” The hospital note also detailed the return trip home via ambulance, which was documented to have occurred from 19:17 (7:17 PM) to 19:45 (7:45 PM). On 02-29-2024 at 2:26 PM, in an interview, the Clinical Supervisor was unaware of Patient #3’s recent Emergency Room visit on 01-12-2024. Indicated aide had not reported anything. The agency failed to ensure the veracity of the visits, and if accurate, failed to ensure was no duplication of services. 10. Review of the clinical record for Patient #7 evidenced overnight visits”

“Instructor qualifications CFR(s): 484.80(e) Standard: Qualifications for instructors conducting classroom and supervised practical training. Classroom and supervised practical training must be performed by a registered nurse who possesses a minimum of 2 years nursing experience, at least 1 year of which must be in home health care, or by other individuals under the general supervision of the registered nurse. This Standard is not met as evidenced by: Based on record review and interview the agency failed to ensure home health aide testing and skills competency was conducted by a registered nurse with 2 of 18 HHA personnel files. (HHA 1 and 6) Findings include: 1. A review of an agency document, revised April 2019 titled, ‘HOME HEALTH AIDE TRAINING’ Policy No. 1-029.1-6 revealed, “PURPOSE To outline a home health aide training program to ensure the competence and skills of home care aides … Criteria … must be registered nurses … “ 2. The review of HHA 1 personnel file revealed the application for home health aide dated 04/08/2023 with previous experience with home health care, the home health aide job description was signed by HHA 1, dated 04/08/2023, a Joint Visit Assessment revealed a completion date of 04/08/2023, signed by Person N, a former office assistant and HHA 1, an Competency Assessment Skills Checklist-Home Health Aide was checked-off with the competency validation indicated by Preceptors Initials and the date was Person N and dated 04/18/2023 for HHA 1. 3. The review of HHA 6, who had their home health aide certificate before their hire date at the agency, personnel file evidenced a document titled, ‘JOINT VISIT ASSESSMENT’ and INITIAL COMPETENCY ASSESSMENT SKILLS CHECKLIST HOME HEALTH AIDE’ completed on 07/18/2023 and signed by Person N, a former office assistant. HHA 6 received their HHA certificate on 07/20/2023. 4. On 02/29/2024 at 1:08 PM, the administrator indicated Person N knew better than to put their name on that form, only an RN can complete it.”

“Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This Standard is not met as evidenced by: Based on record review and interview the agency failed to ensure home health aide assignments and duties were assigned by a registered nurse or other skilled professionals with 1 of 1 agency. Findings include: 1. A review of an agency document dated revised April 2019 titled, Job title/Position Certified Home Health Aide revealed, “JOB DESCRIPTION SUMMARY … The home health aide will be assigned by a Registered Nurse … “ A review of an agency document, revised April 2019 titled, ‘HOME HEALTH STAFFING GUIDELINES’ Policy no. 1-003.1 revealed, “PURPOSE To ensure that staffing guidelines adequately meet workload demands … PROCEDURE 1. Staffing assignments will be determined and documented by the Clinical Supervisor … “ 2. On 02/27/2024 at 9:54 AM home health aide (HHA) 4, the agency’s scheduler indicated that human resources would inform them when HHA’s were ready to be staffed in the field. 3. On 02/28/2024 at 9:30 AM administrative staff 5, the human resource manager indicated when the agency received the HHA’s certificate, they informed HHA 4, the scheduler the HHA is ready to staff. 4. On 02/28/2024 at 10:31 AM, the clinical manager indicated as soon as they receive the HHA’s certificate they inform HHA 4, the scheduler the HHA is ready to be staffed. 410 IAC 17-13-2(a) 410 IAC 17-14-1(m)”

“Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans, and its quality assessment and performance improvement program. This Standard is not met as evidenced by: Based on record review and interview the Governing body failed to assume full legal authority and responsibility for managing and operating a Home Health Agency. Findings include: 1. Review of an agency document revised April 2019 ‘GOVERNING BODY Policy No. 1-002’ stated, “PURPOSE To outline the roles and responsibilities of the Governing Body. POLICY The Governing Body will assume full legal authority, responsibility, decision-making and accountability for the overall management and operations, the provision of services, fiscal operations, human resource management, review of the organization’s budget and operational plans, and its quality assessment and performance improvement (QAPI) program. The Governing Body of A Passionate Helping Hand Home Health Care LLC will serve as the governing authority for the home care program … PROCEDURE 1. Governing Body members will be selected based upon their industry experience, expertise, and professional relationships. … A. Relevant findings of performance improvement activities are consistently provided to the Governing Body to allow for oversight of the quality assessment and performance improvement (QAPI) program. The governing body will ensure the following: 1. That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; 2. That the organizational-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; 3. That clear expectations for patient safety are established, implemented, and maintained; and That any findings of fraud or waste are appropriately addressed. B. Other information relevant to the quality of patient care (i.e., unusual occurrences in care delivered) is also consistently provided through a defined process. The Governing Body will authorize adequate resources and support to establish and maintain an organization-wide performance improvement program. Information related to the performance improvement program will be provided to the Governing Body. … 13. The Governing Body will evaluate the organization’s performance on a regular basis … 19. The Governing Body will comply with the organization’s bylaws in relation to: … H. Overall responsibilities … 20. All actions taken by the Governing Body will be documented in meeting minutes, which will be retained by the organization for a minimum of five (5) years. Minutes will minimally include attendance records, summaries of agenda items and action taken, and motions documented as stated and acted upon …” 2. Review of an agency document dated 01-30-2024 and titled ‘QAPI and Governing Body Minutes’ indicated the meeting was regarding QAPI policy, the resignation of the former Clinical Supervisor, and the appointment of the current Clinical Supervisor. The document failed to evidence discussions of management concerns, operational issues, fiscal or budget-related concerns, any identified patient issues or patient safety concerns, and planning or goal-setting initiatives for any of the above to improve or maintain a high level of service provision. Review of communications from the agency on file with IDOH, failed to evidence notification of the agency’s relocation to: 4701 KEYSTONE AVE SUITE 502, INDIANAPOLIS, IN 46205 - 0089 Review of serial agency plans of care, evidenced the agency’s original address of: “11903 E WELLAND ST STE C, CUMBERLAND, IN 46229-3911”. Review serial agency aide visit notes, evidenced the agency’s original address of: “11903 E WELLAND ST STE C, CUMBERLAND, IN 46229-3911”. 3. . On 02-22-2024 at 10:03 AM, when queried as to who the members of the Governing Body were, the Administrator indicated the members included herself and the office manager, was unsure of the other members, and indicated the office manager could provide a list of members. On 02/23/2024 at 12:02 PM, the office manager attempted to locate the letter they sent to IDOH, but failed to produce the letter, indicated they had sent it but cannot locate the copy. On 02/23/2024 at 12:18 PM, the office manager attempted to locate the change of address form (855) that was sent to Entity NN, but could not; so telephoned them, the office manager was informed by Person OO at Entity NN an email was sent to the administrator on 01/23/2024 indicated they needed the administrator to confirm the address that was the administrators’ personal address. The administrator had replied to the email, indicated the correct address was 4701 N. Keystone Ave, Suite 502, Indianapolis, IN 46205. Person OO indicated it could take a couple of months to process. On 02/23/2024 at 12:43 PM, the office manager indicated they were the one who created and submitted the 855 but did not know how the administrators’ personal address was recorded on the form. On 02-23-2024 at 12:47 PM, when queried as to who the members of the Governing Body were, the office manager indicated the members included herself, the Administrator, the Clinical Supervisor, and one individual from each discipline of the agency. On 02-23-2024 at 2:30 PM the Administrator indicated the office manager (who is non-clinical) “is teaching me, I don’t know, I am still learning the COPs (Conditions of Participation).” On 02-26-2024 at 3:09 PM, the Administrator was asked to provide a copy of the budget. The budget was not received by the end of the survey. On 02-26-2024 at 3:51 PM, when queried, the Administrator indicated was not aware records continued to display the agency’s old address. 410 IAC 17-12-1(b)”

“Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This Standard is not met as evidenced by: Based on record review and interview the agency failed to ensure the Clinical Supervisor provided oversight of all patient care services and personnel. Findings include: 1. Review of an agency document titled ‘Job Title/Position: Clinical Supervisor’ stated, “… The Clinical Supervisor is responsible for ensuring that patient care is coordinated and managed appropriately. The Clinical Supervisor is responsible for ensuring that care and services are delivered appropriately as well as the supervision of clinical personnel … ESSENTIAL JOB FUNCTIONS/RESPONSIBILITIES … 10. Complies with accepted professional standards and principles …” 2. Review of the personnel file for the Clinical Supervisor failed to evidence a job description for the role of Clinical Supervisor and failed to evidence orientation to the role of Clinical Supervisor had been completed. 3. On 02-22-2024 at 10:12 AM, when queried regarding the QA process and who reviews clinical documentation, the Administrator indicated that the office manager (who is not clinical) was the only person doing this, “QA’s nurses’ visits and home health aides and therapy”. On 02-26-2024 at 3:09 PM, when queried as to whether they were familiar with the Federal Regulations for the Administrator and the Clinical Supervisor, the Administrator indicated, not fully, still learning and the Clinical Supervisor indicated was still learning as well. On 02-26-2024 at 3:47 PM, the office manager confirmed she indeed performed the QA function and indicated if something didn’t look right would check with the Clinical Supervisor. Indicated was able to send ‘sticky notes’ back to clinicians to inform of needing correction. On 03-05-2024 at 1:05 PM, when queried as to how home health aide supervisory visits are conducted and how often, the Clinical Manager indicated “every 14 - 30 days” and the Administrator indicated “every episode”. The Clinical Supervisor, when queried if visits were done in person indicated, “if it’s a patient I see”, she may call them, but has done in-person supervisory visits and visits via telephone. The Administrator indicated another nurse had been doing this, and indicated “Some nurses do”, then replied, “So, I guess we shouldn’t be doing that”. 410 IAC 17-12-1(d)”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on record review and interview the agency failed to ensure documentation submitted by employees was appropriately authenticated and dated in 4 of 8 active records reviewed . (Patients #4, 5, 6, and 8) Findings include: 1. A review of an agency’s policy dated revised April 2019 titled, ‘INTERNAL CONTROL SYSTEMS/ACCOUNTABILITIES’ Policy No. 2-043.1 revealed, “PURPOSE … is committed to prevention, detection, and to taking all appropriate action to assure compliance with all legal and regulatory statutes and to promote honest and ethical behavior in all work-related activities … C. … 1. Time sheets are reviewed to determine accuracy and completeness … 3. Clinical/documentation … C. Physician’s orders Mechanisms are currently in place to assure timely signed physician orders … “ 2. A review of the clinical record for Patient 8 evidenced a Physician order dated 02/06/2023 at 2:30 PM for Physical Therapy evaluation failed to evidence a clinician’s signature, a Skilled nursing visit dated 02/13/2024 at 1 PM – 1:45 PM failed to evidence a clinician’s signature, a Home Health Aide (HHA) visit note dated 02/18/2023 failed to evidence a time or HHA’s signature. 3. A review of the clinical record for Patient #4 evidenced a HHA visit on 09/12/2023 at 9:13AM to 6:31 AM which failed to evidence the home health aide’s signature. 4. A review of the clinical record for Patient #5 evidenced a physician order dated 02/07/2024 at 8 AM which failed to evidence a clinician’s signature. 5. A review of the clinical record for Patient #6 evidenced a Physician order dated 02/22/2024 at 4:50 PM which failed to evidence a clinician signature, and a Missed Visit notification for 02/23/2024 failed to evidence a clinician signature and date. 6. On 02/23/2024 at 12:54 the office manager indicated they could go into the electronic medical record and make changes such as clock home health aides in and out, and “manually adjust their times to reflect the time the aides are to be there”. When queried if they were capable of making up a visit to reflect a visit was completed when it wasn’t, the office manager indicated that could be done but we don’t do that. 7. On 02/27/2024 at 1:10 PM the administrator indicated that if documentation was not signed or dated, it was not completed. 410 IAC 17-151(a)(7)”

“Written notice of patient’s rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient’s rights and responsibilities under this rule, and the HHA’s transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This Element is not met as evidenced by: Based on observation, record review, and interview the agency failed to ensure patients or their legal representative were provided with: written notice of the patient’s rights and responsibilities, the agency’s transfer and discharge policies, and ensured they were understandable and accessible, in 1 of 3 home visits observed. (Patient #3) Findings include: 1. Review of an agency document revised April 2019, titled ‘PATIENT BILL OF RIGHTS Policy No. 2-002’ stated, “PURPOSE To encourage awareness of patient rights and provide guidelines to assist patients in making decisions regarding care and for active participation in care planning. POLICY 1. Each patient will be an active, informed participant in his/her plan of care. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. PROCEDURE The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care of their rights … E. Be informed in advance about care to be furnished (including the Medicare Home Health Benefit, if applicable) organization scope of services and service limitations and of any changes in the care to be furnished. F. Be advised in advance of the disciplines that will furnish care, and the frequency of visits proposed to be furnished G. Be advised in advance of any change, orally and in writing, in the plan of care before the change is made. H. The completion of all assessments and care to be furnished, based on the comprehensive assessment. The organization shall ensure that the patient receives all services outlined in the plan of care ... J. The expected outcomes of care, including patient-identified goals, and anticipated risks and benefits: as well as any factors that could impact treatment effectiveness … BB. The organization’s transfer and discharge policies ...” 2. On 2-20-2024 at 9:00 AM during a home visit with Patient # 3, a patient with a history of dementia (an impairment of memory) and an individual with no legal power of attorney (POA), who lived alone, no folder/binder from the agency was found in the patient’s home and when queried the patient could not determine where it would be, or if they had ever had one, and indicated HHA 1 might know. The home visit failed to evidence information from the agency for the patient regarding patient rights and responsibilities and transfer/discharge policies. 3. On 02-29-2024 at 2:26 PM, the Administrator indicated the patient should have had a folder from the agency which would contain admission items (which include patient rights and transfer and discharge policies), and the agency would get a new one out to them. 410 IAC 17-12-3(a) 1 (A)(B)”

“HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator’s name, business address, and business phone number in order to receive complaints. This Element is not met as evidenced by: Based on observation, record review, and interview the agency failed to ensure a patient was furnished with contact information for the Administrator, including name, business address, and business phone number in order to receive complaints, in 1 of 3 home visits observed. (Patient #3) Findings include: 1. Review of an agency document revised April 2019, titled ‘PATIENT BILL OF RIGHTS Policy No. 2-002’ stated, “… PROCEDURE The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care of their rights … CC. The contact information for the agency administrator, including the administrator’s name, business address, and business phone number in order to receive complaints …” 2. On 2-20-2024 at 9:00 AM during a home visit with Patient # 3, there was no folder/binder from the agency in the patient’s home and when queried the patient could not determine where it would be, or if they had ever had one, and indicated HHA 1 might know. 3. On 02-29-2024 at 2:26 PM, the Administrator indicated the patient should have had a folder from the agency which contained admission items (including Administrator’s name and contact information), and the agency would get a new one out to them.”

“OASIS privacy notice CFR(s): 484.50(a)(1)(iii) (iii) An OASIS privacy notice to all patients for whom the OASIS data is collected. This Element is not met as evidenced by: Based on observation, record review, and interview the agency failed to ensure patient had been furnished with an OASIS privacy notice, in 1 of 3 home visits observed. (Patient #3) Findings include: 1. Review of an agency document revised April 2019, titled ‘PATIENT BILL OF RIGHTS Policy No. 2-002’ stated, “… PROCEDURE The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care of their rights … X. Patient privacy rights related to the collection of the Outcome and Assessment Information Set (OASIS): 1. The right to be informed that OASIS information will be collected and the purpose of the collection 2. The right to have the information kept confidential 3. The right to be informed that OASIS information will not be disclosed except for legitimate purposes allowed by the Federal Privacy Act …” 2. On 2-20-2024 at 9:00 AM during a home visit with Patient # 3, there was no folder/binder from the agency in the patient’s home and when queried the patient could not determine where it would be, or if they had ever had one, and indicated HHA 1 might know. 3. On 02-29-2024 at 2:26 PM, the Administrator indicated the patient should have had a folder from the agency which contained admission items (including OASIS Privacy Notice), and the agency would get a new one out to them.”

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on observation, record review, and interview the agency failed to properly assess patients’ capacity to consent to receive services thereby failing to ensure patients retained the right to participate in their care, be knowledgeable about appropriate outcomes of care, including risk and benefit, and failed to include factors which could impact treatment effectiveness, in 1 of 3 home visits observed. (Patient #3) Findings include: 1. Review of an agency document revised April 2019, titled ‘PATIENT EDUCATION PROCESS Policy No. 4-049’ stated, “… POLICY Patients and family/caregivers will receive education in verbal, visual, and written form, as appropriate. The scope of teaching will be determined by assessing the needs, abilities, learning preferences, and readiness to learn of the patient and family/caregiver, as well as by the plan of care, goal and established outcomes … PROCEDURE 1. The clinician will assess, plan, implement, and evaluate the following on each patient and family/caregiver, as appropriate: … D. The ability and readiness of the patient and family/caregiver to learn … H. Physical and/or cognitive limitations, as well as communication and language barriers to learning … 2. Based on the above, the assessments will be used as the basis, for planning patient and family/caregiver education. In the event that any barriers to learning exist, these barriers, as appropriate, will be discussed with the patient and family/caregiver as well as the Clinical Supervisor. If they cannot be overcome, the patient’s physician will be contacted … 5. If a patient lives alone and there is no one able or willing to receive the instruction, the physician will be informed, and this information will be documented in the clinical record. 6. Unless otherwise ordered by the physician (or other authorized licensed independent practitioner), the patient and family/caregiver will receive verbal and, as appropriate, written instructions that are in plain language …” 2. On 2-20-2024 at 9:00 AM during a home visit with Patient # 3, the patient was found to be alone in their apartment. Memory deficits were apparent, the patient asked similar questions multiple times (i.e. “Would you like a drink?”, “Do you live around here?”, “Would you like a seat?”), despite having been answered moments previously. There was no folder/binder from the agency in the patient’s home and when queried the patient could not determine where it would be, or if they had ever had one, and indicated HHA 1 might know. 3. On 02-26-2024 at 3:22 PM when queried as to whether Patient #3 had cognitive issues, the Clinical Supervisor indicated, “yes” they did. When queried as to whether the patient had next of kin/guardian/county resource case manager, the Administrator asked the Clinical Supervisor if the agency had figured out guardianship for the patient, the office manager indicated knew of care manager with a waiver program and offered the contact info. When queried as to whether the patient ought to be making his own decisions, the Clinical Supervisor indicated the patient, “shouldn’t be”. When queried as to how consent was obtained in order to service the patient, no reply was offered. When queried as to whether the agency allowed cognitively impaired clients to sign for consent, no reply was offered. On 2-27-2024 at 3:21PM, Person MM, a care manager, with Entity LL, a Medicaid waiver program indicated Patient #3 was, “confused 95% of the time”, indicating the patient did not currently have a POA. Person MM indicated had been seeking guardianship for the patient and was awaiting signed paperwork from the patient’s physician for this, indicating the process will not be speedy. 410 IAC 17-12-3(b)(2)(D)(i)(AA)(BB) 410 IAC 17-12-3(b)(2)(D)(ii)(AA)(BB)”

“State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This Element is not met as evidenced by: Based on observation, record review, and interview the agency failed to ensure the patient was furnished with the State Toll-free Home Health Hotline Number, in 1 of 3 home visits observed. (Patient #3) Findings include: 1. Review of an agency document revised April 2019, titled ‘PATIENT BILL OF RIGHTS Policy No. 2-002’ stated, “… PROCEDURE The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care of their rights … T. Receive in writing, prior to the start of care, the telephone numbers for the State Home Health Hotline … including hours of operation, and the purpose of the hotlines to receive complaints or questions about the organization …” 2. On 2-20-2024 at 9:00 AM during a home visit with Patient # 3, the patient was found to be alone in their apartment. Memory deficits were apparent, the patient asked similar questions multiple times, despite having been answered moments previously. There was no folder/binder from the agency in the patient’s home and when queried the patient could not determine where it would be, or if they had ever had one, and indicated HHA 1 might know. 3. On 02-29-2024 at 2:26 PM, the Administrator indicated the patient should have had a folder from the agency which contained admission items (including the State Home Health Hotline telephone number), and the agency would get a new one out to them. 410 IAC 17-12-3(b)(2)(C)”

“Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This Element is not met as evidenced by: Based on observation, record review, and interview the agency failed to ensure the patient was furnished with the contact information for Federal and State funded entities, in 1 of 3 home visits observed. (Patient #3) Findings include: 1. Review of an agency document revised April 2019, titled ‘PATIENT BILL OF RIGHTS Policy No. 2-002’ stated, “… PROCEDURE The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care of their rights … DD. The names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: 1. Agency on Aging 2.Center for Independent Living 3. Protection and Advocacy Agency 4. Aging and Disability Resource Center 5. Quality Improvement Organizations …” 2. On 2-20-2024 at 9:00 AM during a home visit with Patient # 3, there was no folder/binder from the agency in the patient’s home and when queried the patient could not determine where it would be, or if they had ever had one, and indicated HHA 1 might know. 3. On 02-29-2024 at 2:26 PM, the Administrator indicated the patient should have had a folder from the agency which contained admission items (including contact information for Federal and State funded entities), and the agency would get a new folder out to the patient.”

“Investigate complaints made by patient CFR(s): 484.50(e)(1)(i) (i) Investigate complaints made by a patient, the patient’s representative (if any), and the patient’s caregivers and family, including, but not limited to, the following topics: This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure complaints were investigated when made by patients or representatives in 1 of 2 discharge records reviewed. (Patient #2) Findings include: 1. A review of an agency’s policy titled, ‘PATIENT BILL OF RIGHTS Policy No.2-002.1’ dated April 2009, revised April 2019 revealed, “ … C. Voice grievances regarding treatment or care that is (or fails to be) furnished … D. Receive an investigation by the organization of complaints made by the patient or the patients family … regarding treatment or care that is (or fails to be) furnished … “ 2. A review of the clinical record for Patient #2, start of care 11/21/2022, contained an OASIS (Outcome and Assessment Information Set is the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality) Discharge Non-visit assessment dated 10/06/2023, and electronically signed by Person B, a former RN on 10/06/2023 indicated the Physician agreed with plan to discharge and that patient had moved in with family until they could find placement in an assisted living facility. Per the OASIS note, Patient #2 was to receive Home Health Aide Services 5 times a week for 9 weeks. A review of the clinical record for Patient #2 for the certification period of 09/17/2023 - 11/15/2023 revealed home health aide (HHA) services were ordered for 5 times a week for 9 weeks. Documentation evidenced 1 HHA visit conducted on 09/18/2023 from 4 PM to 10 PM and a missed visit dated 10/06/2023, the date of discharge. There were no other visits conducted as ordered. 3. On 02/27/2024 at 1:12 PM, during a phone call for a discharged patient’s record to validate services provided, Person R indicated the agency had not staffed their family member for home health aide services as they were scheduled. They had called the agency several times complaining, and talked to different staff members who answered the phone(couldn’t remember whom they spoke with) but did recall they had spoken to the administrator a couple of times about the home health aides not showing up. Indicated there was a camera in the home, and they know when someone is there or not. Person R indicated the patient was to receive 8 hours a day of home health aide services 5 days a week and Patient #2 rarely received the ordered home health aide services. Person R further indicated Patient #2 did not move in with family and was still in their own home, with a different agency providing services. 4. A review of the complaint binder failed to evidence of a complaint from Patient #2 nor their family member. 5. On 02/29/2024 at 1:20 PM, the Administrator indicated a complaint is anything a patient or their representative is not happy about. The Administrator indicated the complaint would be handed over to the nurse to follow up, investigate, and find a resolution to the problem and would document the process. When queried if they were aware of speaking with a patient’s representative about home health aides not showing up, the Administrator indicated they hadn’t spoken to anyone about staff not showing up, and indicated the agency doesn’t have that problem.”

“Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This Element is not met as evidenced by: Based on record review and interview, the agency failed to document complaints made by patients or their representatives or any resolution of the complaint as evidenced by 1 of 2 discharge records reviewed. (Patient 2). Findings include: 1. A review of an agency’s policy titled, ‘COMPLAINT/GRIEVANCE PROCESS Policy No. 2-008.1’ dated 2009, revised April 2019 revealed, “ … POLICY Any difference of opinion, dispute, or controversy between a patient or family/caregiver or patient representative and A Passionate Helping Hand Home Health Care LLC concerning any aspect of service … will be considered a grievance. The organization will investigate complaints regarding treatment or care … PROCEDURE 1. The organization staff member receiving the complaint will discuss, verbally and in writing, the grievance with a supervisor within five (5) working days of the alleged grievance. The supervisor will investigate the grievance within five (5) days after receipt of such grievance and will make every effort to resolve the grievance to the patient’s satisfaction … 4. Complaints and any action taken will be documented on a complaint form … 6. Resolution information will be communicated in writing to the patient or his/her representative filing the complaint … “ 2. A review of the discharged clinical record for Patient #2 for the certification period of 09/17/2023-11/15/2023 revealed home health aide (HHA) services were ordered for 5 times a week for 9 weeks with 1 HHA visit conducted on 09/18/2023 from 4 PM to 10 PM and a missed visit dated 10/06/2023, the date of discharge. 3. On 02/27/2024 at 1:12 PM, an interview was conducted with Person R to validate services provided. Person R indicated the agency had not staffed their family member as they were scheduled. They called the agency several times complaining, and talked to different staff who answered the phone and recalled speaking to the Administrator a couple of times about the home health aides not showing up. Indicated there was a camera in the home, and they know when someone is there or not. Person R indicated the patient was to receive 8 hours a day of home health aide services 5 days a week and Patient #2 rarely received the ordered home health aide services. Person R further indicated Patient #2 did not move in with family and was still in their own home, with a different agency providing services. 4. A review of the complaint binder failed to evidence a complaint from Patient #2 nor their family member was present. 5. On 02/29/2024 at 1:20 PM, the Administrator indicated the complaint would be handed over to the nurse to follow up, investigate, and find a resolution to the problem and would document the process. When queried if they were aware of speaking with a patient’s representative about home health aides not showing up, the Administrator indicated they hadn’t spoken to anyone about staff not showing up, and indicated the agency doesn’t have that problem.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, record review and interview the agency failed to ensure the comprehensive assessment incorporated a thorough review of patients’ medications, including high-risk medications (i.e. insulin) for 2 of 8 active clinical records reviewed. (Patients #3 and #8) Findings include: 3. A review of the clinical record for Patient #8 revealed a Home Health Certification and Plan of Care document for the certification period of 01/25/2024 – 03/24/2024 which evidenced diagnoses but not limited to Type 2 diabetes mellitus (a long-term condition in which the body has trouble controlling blood sugar and using it for energy) and legal blindness, as defined in USA. Mental/Cognitive Status Oriented x 3, Forgetful Caregiver Status: Patient is blind, lives in residential home and has 24-hour supervision, makes own decisions. Psychosocial Status: Barriers to Heath Status (Multiple co-morbidities, Multiple health providers, Other (Blind) Comments: The patient is legally blind and requires max assistance of another person for safety to prevent falls. Patient #8 medications included but were not limited to Insulin Glargine (a synthetic version of human insulin) 100 units/milliliter subcutaneous (applied under the skin) solution 60 milliliters inject 15 units subcutaneously daily, Lantus Solostar Pen ( Lantus contains the drug insulin glargine, 3-mL prefilled SoloStar pen that contains 100 units of insulin per milliliter used manage blood sugar levels with just one dose a day and delivers the precise dose you dial time after time. People who are blind or have vision problems should not use the Lantus SoloStar prefilled pen without help from a person trained in its use )100 units/milliliter subcutaneous solution inject 20 units by subcutaneous route 1 time daily at bedtime, intramuscular (IM) (administered into a muscle), and Novolog Flexpen (rapid-acting insulin is mealtime insulin made to help control blood sugar spikes) Inject 8 units by subcutaneous route 3 times daily with meals intramuscular (IM). Patient #8 was to receive SN (skilled nursing) 1 time a month for 2 months, PT (Physical Therapy) 2 times a week for 9 weeks, and HHA (home health aides) 7 times a week for 9 weeks. The Home Health Certification and Plan of Care failed to evidence correct routes for medications. hen this writer queried what kind and how much insulin they take, Patient #8 replied, “I know what medicine I take, 5 units of insulin at night”. On 03/05/2024 at 10:43 AM, Patient #8 indicated they go to dialysis on Monday, Wednesday, and Fridays, that the home health aide staff do not go with them, and Patient #8 gave their own insulin shot at night, 5 units, in a prefilled syringe from their pharmacy. 4. On 03/04/2024 at 1:37 PM, the clinical manager indicated they weren’t sure how the insulin is managed but thought Patient #8 gave their own injections and would have to check on the types of insulin, route, and dosage. On 03/06/2024 at 8:23 am, Person J, a community health liaison Registered Nurse (RN) at Entity 8 returned a phone call and indicated they were meeting with Person T, the physician for Patient #8 later in the morning. When this writer expressed concerns about Patient #8 insulin administration, Person J indicated they would fax the history and physical, medication list, and last hospital admission to this writer for clarification. On 03/06/2024 at 3:26 PM, Person J called this writer, indicating they weren’t comfortable faxing the patient’s health information. This writer indicated they would send the release of protected health information letter to them, Person J gave this writer their email address, then indicated Patient #8 is refusing Person J to release their health information to anyone. This writer sent the PHI letter to Person J on 03/26/2024 at 3:32. This writer did not receive the patient’s history and physical, medication profile, and last hospital admission. 410 IAC 17-14-1(a)(1)(B) 1. Review of an agency document revised April 2019, titled ‘INITIAL AND COMPREHENSIVE ASSESSMENT Policy No. 4-018’ stated, “POLICY … O. Review of medication history, as applicable to care and service and current medication use, including prescription, over-the-counter medications and herbal medications, and allergic reactions, identifying significant drug interactions, duplicative drug therapy, potential adverse effects and drug reactions, ineffective drug therapy, effectiveness of drug therapy, immediate desired effects, unusual and unexpected effects, drug therapy associated with lab monitoring, changes in patient’s condition that contraindicates continued administration, significant side effects and noncompliance with therapy … “ Review of an agency policy revised April 19, titled ‘ONGOING ASSESSMENTS Policy No. 4-019’ stated, “… POLICY … the clinician will reassess the patient for: … M. Compliance to treatment and/or medications … 7. The physician will be notified to verify any changes in medications, including over-the-counter medications (which might interact or be duplicative with other patient medications and treatment/interventions that require physician approval …” Review of an agency document revised April 2019, titled ‘REASSESSMENTS/RECERTIFICATION Policy No. 4-020’ stated, “… PROCEDURE … 3. The update of the comprehensive assessment must, at a minimum, include: … B. Drug regimen review of all medications for drug interactions, polental adverse effects and drug reactions, duplicative drug therapy, ineffective drug therapy, significant side effects, significant drug interactions …” Review of an agency document revised April 2019, titled ‘MEDICATION PROFILE Policy No. 4-024’ stated, “POLICY … Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications … 2. A drug regimen review will be performed at the time of admission, when updates to the comprehensive assessments are performed … and with the addition of a new medication. The review will be performed by qualified personnel and will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicative drug therapy, and noncompliance with drug therapy … A. Using the medication profile to evaluate the use of medications in the home setting. The medication profile includes, but is not limited to; all current medications, date prescribed, name of medication, dose, frequency, drug classification, date discontinued … 5. Based on review of the medication profile as well as the written material, changes in the plan of care may be required. 6. Any conclusions and findings of patient medication use or monitoring should be communicated to the pharmacist, when appropriate, and other clinicians. 7. Deviations from taking medications as ordered will be documented in clinical notes, and the physician (or other authorized licensed independent practitioner) will be notified. …” 2. Review of the electronic clinical record for Patient #3 evidenced a Start of Care date of 06-20-2023, a comprehensive assessment dated 12-13-2023 for the certification period of 12-17-2023 to 02-14-2024, and contained diagnoses which included but were not limited to: Diabetes Mellitus (a disease in which your blood glucose, or blood sugar, levels are too high). The assessment contained a section titled ‘Endocrine/Hematological Assessment’ which indicated, “… Diabetic Management Option … Insulin: Insulin Administration LANTUS SOLOSTAR PEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 50 units subcutaneous route 2 times every day …” and failed to include ordered Humalog insulin. The clinical record further evidenced a comprehensive assessment, dated 02-12-2024 for the certification period of 02-15-2024 through 4-14-2024. The assessment contained a section titled ‘Endocrine/Hematological Assessment’ which also indicated, “… Diabetic Management Option … Insulin: Insulin Administration LANTUS SOLOSTAR PEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 50 units subcutaneous route 2 times every day …” This assessment also failed to include ordered Humalog insulin. Review of an outside document, dated 11-20-2023, titled ‘Office Visit’ indicated Patient #3 had been seen by Doctor I, “ … Lantus Solostar U 100 insulin 100 units/ml (3ml) inject 25 units by subcutaneous route 2 times every day …” Review of an outside document, dated 01-19-2024, titled ‘Office Visit’ indicated Patient #3 had been seen by Doctor I, “ … Start date 12/11/23 Humalog KwikPen (U 100) insulin 100units/ml subcutaneous inject TID (three times daily) per insulin protocol, max dose 44 units … Start Date 12/26/23 Lantus Solostar U-100 insulin 100 units/ml 3ml subcutaneous pen inject 25 units by subcutaneous route two times every day …” On 02-22-2024 at 10:12 AM, the Administrator indicated medications were reconciled “every time we are in the home.” On 02-28-2024 at 11:34 AM, in a telephone interview regarding Patient #3 with Person J, of Doctor I’s office, reviewed both of the insulins ordered and Person J indicated the Humalog order was odd, and would check into this further, as ‘44 units’ and a ‘sliding scale’ were both written. Indicated the Lantus order should not be 50 units, but rather 25 units, but would clarify this further. Expressed concern if the patient were truly taking 50 units of Lantus twice daily, this was too much medication, and besides the patient would run out of medication too soon and insurance may not cover this. Indicated no one from the agency had called to request the patient’s medication list and no requests had been made for copies of recent office visits. Indicated had not received any telephone communication from A Passionate Helping Hand since March of 2023. On 02-28-2024 at 4:00 PM, the Clinical Supervisor was made aware of the discrepancies with Patient #3’s insulin orders, indicated she had spoken with Person R, Doctor I’s medical assistant, to request new orders today and reconcile medications and was awaiting a reply. When queried as to whom she usually speaks to at Doctor I’s office, and when the last call may have been, indicated could not remember.”

“Within 48 hours of the patient’s return CFR(s): 484.55(d)(2) Within 48 hours of the patient’s return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This Element is not met as evidenced by: Based on observation, record review and interview the agency failed to ensure patients were resumed within 48 hours after returning home from a hospital admission for 1 of 8 active clinical records, 1 of 10 active and closed records reviewed. (Patient #10) Findings include: 1. Review of an agency document revised April 2019, titled ‘REASSESSMENTS/RECERTIFICATION Policy No. 4-020’ stated, “PURPOSE To outline the requirements for ongoing updates to the comprehensive assessment ... OASIS assessments for ... resumption of care ... will be completed within the mandated time frames ...” 2. Review of the clinical record for Patient #10 with a start of care date of 11-12-2023 contained a comprehensive assessment for a Resumption of Care dated 02-26-2024, for the certification period of 01-07-2024 through 03-06-2024 and contained diagnoses which included but were not limited to: anoxic brain injury (caused by a complete lack of oxygen to the brain, which results in the death of brain cells after approximately four minutes of oxygen deprivation). A section titled ‘Comments’ stated, “Patient has Cognitive Impairment related to Anoxic Brain Injury. Patient requires constant supervision to be safe and not would not be considered safe for him … to leave home unattended … PATIENT’S HX [sic]REAVLS … THAT PATIENT WAS IN PAIN AND COULDN’T GET UP SO [Patient #9] CALLED 911 AND SENT HIM TO HOSPITAL, COMMUNITY HOSPITAL SOUTH ADMITTED [Patient #10] THEN SENT … TO NURSING HOME FOR REHAB …” The record evidenced a transfer OASIS had been completed, and an auto-generated transfer summary had been sent to the ordering physician, returned signed by the physician. Further review of the clinical record failed to evidence communication notes or faxes between the agency and Entity FF had been documented. Review of Discharge paperwork from Entity FF, a skilled nursing facility, indicated Patient had been admitted on 02-14-2024, diagnosed with osteonecrosis (when part of the bone does not get blood flow and dies) of the right femur, and discharged home on 02-23-2024 with orders for Home Health Services. Review of an aide visit note dated 2-23-2024 with a clock-in time of 4:00 PM and clock-out time of 11:00 PM, indicated the patient received a Personal Services Aide services from Aide 23 with Entity U, the agency’s sister company, a personal services agency, the same evening the patient was discharged home from Entity FF. 3. On 03-05-2024 at 9:24 AM, in an interview with Registered Nurse (RN) 1, indicated had resumed services for Patient #10 on 02-26-2024, three days after being discharged home from a skilled facility, and indicated was unaware the patient should have been resumed within 48 hours of returning home from the skilled facility. Indicated the patient’s family member did not make the agency aware the patient was home. Understood an aide had serviced the patient the same day the patient returned home, suspected the aide was already in the home. When queried as to who had provided training for their nursing position, indicated at first it was Person B, who subsequently left the agency, then the office manager and the Administrator. When queried as to the credentials of these two individuals, indicated the office manager was not a nurse, and the Administrator was an LPN (Licensed Professional Nurse), and when queried as to whether there were any other RNs available in the agency indicated, “Well, [the Clinical Supervisor], we are learning a lot together” and indicated the Clinical Supervisor had been more a part of the training recently. On 03-05-2024 at 10:21 AM, the Administrator indicated RN 1 was new, should have known a Resumption of Care needed to occur within 48 hours of the patient’s return home and believes this was covered in the nurse’s orientation, and the agency “had confused” RN 1 by being inconsistent with training related to RN 1’s position and responsibilities.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure patients’ plan of care evidenced the extent of the patient’s mental, psychosocial, and cognitive status, the types of services required, the frequency and duration of visits, the extent and impact of functional limitations, all medications and treatments, a description of patients risk for emergency department visits and hospital readmission, all necessary interventions to address underlying risk factors, patient-specific interventions and education, measurable outcomes and goals identified by the agency, in 1 of 8 active clinical records reviewed. (Patient #3) Findings include: 1. Review of an agency document, revised April 2019, titled ‘CARE PLANNING PROCESS Policy No. 4-001’ stated, “… POLICY ... The individualized plan of care includes: … 3. Based on the assessment and conclusions, the plan of care will include but not be limited to: A. Patient specific interventions and education B. Identified patient problems and needs, including functional limitations activities permitted, nutritional requirements C. Reasonable, measurable, and individualized goals and outcomes identified by the organization and the patient D. Specific services and treatments to be provided E. Actions to be taken to meet the patient goals F. Type, frequency, and duration of above actions ... J. The patient’s mental, psychosocial and cognitive status K. All medications L. Safety measures to protect against injury M. A description of patient risk for emergency department visits and hospitalization readmission and all necessary interventions to address all underlying risk factors ... 10. Clinicians will inform the patient’s physician of any changes that suggest a need to alter the plan of care ... 12. problems and/or needs related to patient’s condition … patient family/caregiver support systems, and relevant medication monitoring will be included in the plan of care ...” 2. On 2-20-2024 at 9:00 AM during a home visit with Patient # 3, the patient was found to be alone in their apartment. Memory deficits were apparent, patient asked similar questions multiple times (i.e. “Would you like a drink?”, “Do you live around here?”, “Would you like a seat?”), despite having been answered moments previously. The patient presented with a right below-the-knee amputation and left toes were amputated, fingers to the right hand had been amputated. Indicated was learning to use their left hand to write their signature. Was able to hold his cell phone with the right hand. The patient transferred themselves from their bed to their electric wheelchair. When queried as to whether the patient had their insulin yet today and how the patient receives their insulin, indicated “[Home Health Aide {HHA} #1] will give me my shots”, and indicated this twice. 3. Review of the electronic clinical record for Patient #3 evidenced a Plan of Care dated 02-12-2024 for the certification period of 02-15-2024 through 4-14-2024 and contained diagnoses which included, but were not limited to: Diabetes Mellitus (blood glucose, or blood sugar, levels are too high), Hemiplegia (a condition caused by brain damage or spinal cord injury that leads to paralysis on one side of the body, causing weakness, problems with muscle control, and muscle stiffness with degrees of symptoms varying) following cerebral infarction (ischemic stroke, occurs as a result of disrupted blood flow to the brain can cause parts of the brain to die off) affecting non-dominant left side, long term use of insulin, acquired absence of right leg below the knee, acquired absence of left toes, dependence on wheelchair, history of falling. The plan of care contained a medication list which included but was not limited to: “HUMALOG (a fast-acting, mealtime insulin used to control high blood sugar in individuals with diabetes) KWIKPEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 44 units by subcutaneous route every day as per sliding scale (varies the dose of insulin based on blood glucose level, the higher the level, the more insulin taken, this method is more precise than fixed dose insulin) subcutaneous (SQ)” and, “LANTUS (a long-acting insulin that starts to work about 2 hours after injection and lasts for up to 24 hours to maintain normal blood sugar levels) SOLOSTAR PEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 50 units subcutaneous route 2 times every day subcutaneous”, the record failed to evidence a sliding scale for insulin. The plan of care indicated the patient was to receive Skilled Nursing every 30 days for supervisory visits and one (1) time every 56-60 days for Home Health Care Recertification, and was to receive Home Health Aide services 5 times per week, “up to 8 hours per day” for safety with ADLS, IADLS, personal hygiene, grooming, medication reminders, light housekeeping, and meal prep. The 60-day summary indicated, “… Denies fall, injury, ED visits or hospitalizations or medication concerns this home health episode … plan of care reviewed with patient, patient in agreement with plan and denies any need for changes at this time …” A section titled ‘Nursing’ contained the following nursing interventions, “… Patient assessed to be at high risk for emergency department visit and/or hospital readmission. All necessary interventions to address the underlying risk factors are as follows: SN to minimize/eliminate risk for hospitalization due to problems associated with physical limitations … SN to assess and instruct patient on mitigation of hospital risks: due to problems associated with: polypharmacy/high risk medications: DM, PVD, physical limitations: poor health literacy and patient support …” and failed to evidence patient-specific details. In a section titled ‘Risk Factors’ stated, “… SN to assess diabetic status, identify any signs or symptoms of impaired diabetic function, report significant changes to physician … SN to instruct on self-management program to include, disease process, who to contact if signs and symptoms persist or worsen as well as dietary measures, medication management, foot care precautions, blood sugar monitoring, hypo/hyperglycemia management and long term complications … SN to prepare/teach patient/caregiver to administer insulin [dosage and frequency] using aseptic technique … SN to perform medication review each skilled nursing visit and reconcile medications as indicated. SN to instruct on all new and changed medications and reinforce teaching related to use of medications a part of disease process or demonstrated knowledge deficit …” A section titled, ‘Goals’ stated, “… Patient will demonstrate compliance with medication regimen as evidenced by correct administration, reporting side effects or adverse reactions by EOE [end of episode]. Patient demonstrates ability to effectively manage medication regimen by EOE … Patient will demonstrate competence with self-management of DM [Diabetes Mellitus] as evidenced by adherence to the medication regimen, ability to identify s/s necessitating contact with medical professionals, diet regimen guidelines, activity compliance and symptom management by EOE …” The plan of care failed to evidence how the patient’s functional impairments: the extent of cognitive impairment, poor manual dexterity related to the patient’s absence of fingers of the right dominant hand, recent vision correction surgery, and lack of family/caregiver availability or support, collectively affected the patient’s ability to care for themselves and provide for their own needs. The plan of care failed to evidence whether the patient’s understanding of diabetic management had been assessed and was appropriate, failed to evidence serial blood glucose readings had been tracked/monitored, failed to evidence physician-directed and patient-specific blood glucose parameters, failed to evidence return-demonstrations were performed and the patient was found to be proficient in: self-monitoring of blood glucose levels, accurate calculation of insulin dosing based on a sliding scale, and self-administration of injectables. The plan of care failed to evidence the skilled nurse had identified the patient’s skilled nursing needs, failed to secure orders from the physician for additional skilled nursing visits to provide skilled monitoring, education/teaching, and interventions outlined in the plan of care, and by extension failed to measure or make any progress toward the goals indicated. Review of the paper clinical record for Patient #3 evidenced an order from Doctor I’s office dated 09-20-2023 which stated, “… Referrals; Home Health Evaluate and treat … Clinical Indications/Reason for Referral: insulin administration/medication management …” Review of an outside hospital document dated 01-12-2024, detailed Patient #3’s visit to the Emergency Room related to a fall, elevated Blood Sugar reading of 468 mg/dl, general weakness, and cellulitis of the left lower extremity. The document also evidenced a diagnosis of dementia, and the patient had been released home with antibiotics. 3. On 02-22-2024 at 10:12 AM, the Administrator indicated medications were reconciled “every time we are in the home.” On 02-28-2024 at 11:34 AM, in a telephone interview regarding Patient #3 with Person J, of Doctor I’s office, indicated the intent of home health services was home care nursing would provide insulin administration and management. Was unaware patient was not receiving these services. Indicated the patient had “cognitive deficits for sure”, indicated was always accompanied by HHA #1 for office visits, and was not aware HHA #1 was an employee of the Home Health Agency. Indicated HHA #1 has put themselves on the patient’s list of contacts to release information to. Indicated they were aware the patient was hospitalized on 1-12-2024 because they could see the patient’s home from the office and saw the day the ambulance was there but had not been informed by the agency about the Emergency Room visit. Indicated had not received any telephone communication from A Passionate Helping Hand since March of 2023, specifically no requests for verbal orders. Person J reviewed the insulin ordered and indicated the Humalog order was not accurate, and would check into this further, as “44 units” and a “sliding scale” were both mentioned. Indicated the Lantus order should not be 50 units, but rather 25 units, but would clarify this further. Expressed concern that if the patient were truly taking 50 units of Lantus twice daily, this was too much medication, the patient would run out of medication too soon, and insurance may not cover this. Indicated no one from the agency had called to request the patient’s medication list and no requests had been made for copies of recent office visits. On 02-28-2024 at 4:00 PM, the Clinical Supervisor was made aware of the discrepancies with Patient #3’s insulin orders, she indicated she had spoken with Doctor I’s medical assistant today to request new orders and reconcile medications. On 02-29-2024 at 9:50 AM, in an interview with the Clinical Supervisor, indicated had not ever seen the paper document with the physician’s order for nursing to provide insulin administration and medication management and was surprised to learn the agency had this document in their possession since September of 2023. On 02-29-2024 at 2:26 PM, in an interview with the Clinical Supervisor, was unaware that Patient #3 had an amputation of the right fifth digit during their time under the agency’s care, was unaware the patient had undergone vision correction surgery and was unaware of the patient’s recent fall that led to an ER visit on 01-12-2024, with an elevated blood sugar reading of 468mg/dl, and cellulitis of the left lower leg and was unaware the patient had been sent home with antibiotics at that time. On 03-05-2024 at 12:52 PM, the Administrator and Clinical Supervisor indicated HHA #1 and #2 had called to inform that Patient #3 was just hospitalized with an infection to the left hand, elevated blood sugars, and ulcers to the left leg and left heel, believing this to be due to the way the patient’s leg rests on the prosthetic. On 03-05-2024 at 1:16 PM, the Administrator indicated if Patient #3 required 24-hour home care, maybe they needed a skilled facility. 410 IAC 17-13-1(a)(1)(C) 410 IAC 17-13-1(a)(1)(D)(i, iii, iv, v, vi, ix, xii)”

“All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This Element is not met as evidenced by: Based on record review and interview the agency failed to include all orders in the plan of care by failing to identify they were in possession of a written physician’s order for Skilled Nursing to provide insulin administration and medication management for a home health patient, in 1 of 8 active clinical records reviewed. (Patient #3) Findings include: 1. Review of an agency document, revised April 2019, titled ‘CARE PLANNING PROCESS Policy No. 4-001’ stated, “PURPOSE To provide direction to the clinicians providing direct patient care ... POLICY ... The care planning process will be documented in the plan of care, individualized discipline-specific care plans (if applicable), clinical notes, medication profiles, care conference/summary forms, and discharge/clinical summaries ... 1. Individualized plan of care: The patient-specific clinical plan of care includes: ... D. All patient care orders ...” 2. Review of the electronic clinical record for Patient #3 evidenced a Plan of Care dated 02-12-2024 for the certification period of 02-15-2024 through 4-14-2024 and contained diagnoses which included, but were not limited to: Diabetes Mellitus (a disease in which your blood glucose, or blood sugar, levels are too high), Hemiplegia (a condition caused by brain damage or spinal cord injury which leads to paralysis on one side of the body, causing weakness, problems with muscle control, and muscle stiffness with degrees of symptoms varying depending on the location and extent of the injury) following cerebral infarction (also called ischemic stroke, occurs as a result of disrupted blood flow to the brain due to problems with the blood vessels which supply it, the lack of adequate blood supply to brain cells deprives them of oxygen and vital nutrients which can cause parts of the brain to die off) affecting non-dominant left side, long term use of insulin, acquired absence of right leg below the knee, acquired absence of left toes, dependence on wheelchair, history of falling. The plan of care included a medication list which included but was not limited to: “HUMALOG (a fast-acting, mealtime insulin used to control high blood sugar in individuals with diabetes) KWIKPEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 44 units by subcutaneous route every day as per sliding scale subcutaneous (SQ)” and, “LANTUS (a long-acting insulin which starts to work about 2 hours after injection and lasts for up to 24 hours to maintain normal blood sugar levels) SOLOSTAR PEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 50 units subcutaneous route 2 times every day subcutaneous”, the record failed to evidence a sliding scale. The plan of care indicated the patient was to receive Skilled Nursing every 30 days for supervisory visits and one (1) time every 56-60 days for Home Health Care Recertification, and was to receive Home Health Aide services 5 times per week, “up to 8 hours per day” for safety with ADLS, IADLS, personal hygiene, grooming, medication reminders, light housekeeping, and meal prep. Review of the paper clinical record for Patient #3 evidenced an order from Doctor I’s office dated 09-20-2023 which stated, “… Referrals; Home Health Evaluate and treat … Clinical Indications/Reason for Referral: insulin administration/medication management …” 3. On 02-29-2024 at 9:37 AM, in an interview with the office manager, regarding a written order for Patient #3 found in the paper chart, she indicated anything uploaded to the electronic record would be found in “Documents”, she was also unable to locate this order in the electronic medical record (EMR) system and the only copy appeared to be housed in the patient binder. The office manager indicated the last upload to the chart appeared to be 08-30-2023. On 02-29-2024 at 9:50 AM, in an interview with the Clinical Manager, indicated had not ever seen the paper document with the physician’s order for nursing to provide insulin administration and medication management and was surprised to learn the agency had this document in their possession since September of 2023. Indicated if the order had been seen “we would have been providing that for [Patient #3]” indicated would be contacting the physician and asking for daily visits now, if not three times a day, and indicated they had staff who could cover this.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on observation, record review, and interview failed to ensure services were provided and treatments were administered as ordered by the physician, in 2 of 9 clinical records reviewed. (Patient #3, 4, 6, and 8) Findings include: 1. Review of an agency document, revised April 2019, titled PATIENT BILL OF RIGHTS Policy No. 2-002’ revealed, “ … PURPOSE To encourage awareness of patient rights and provide guidelines to assist patients in making decisions regarding care and for active participation in care planning. … PROCDURE … H. The completion of all assessments and care to be furnished, based on the comprehensive assessment. The organization shall ensure that the patient receives all services outlined in the plan of care … “ Review of an agency document, revised April 2019, titled ‘CARE PLANNING PROCESS Policy No. 4-001’ stated, “PURPOSE To provide direction to the clinicians providing direct patient care ... PROCEDURE ... the clinician ... will develop the plan of care based on the patient’s identified needs and will review it with the patient and family/caregiver. 2. All clinicians will consider their conclusions of initial and ongoing assessments in their care planning process including, but not limited to: A. Individualized patient needs and resultant problems related to care, functional status, and family/caregiver support system. 3. Based on the assessment and conclusions, the plan of care will include but not be limited to: ... B. Identified patient problems and needs ... D. Specific services and treatments to be provided ... F. Type, frequency, and duration of above actions ... “ . 2. A review of the clinical record for Patient #4 revealed a Home Health Certification and Plan of Care document for the certification period of 01/25/2024 – 03/24/2024 which evidenced diagnoses but not limited Cerebral Palsy (a group of disorders which affect a person’s ability to move and maintain balance and posture. Cerebral means having to do with the brain and palsy means weakness or problems with using the muscle[s]). Patient #4 was to receive HHA (home health services) 5 times a week for 9 weeks up to 8 hours a day. A review of the clinical record for Patient #4 revealed a document titled ‘STATE HHA CARE PLAN’ (a plan for home health aides to follow for the patient) revealed Patient #4 was to receive HHA (home health aide) services 5 times a week for 9 weeks. A review of HHA visit notes evidenced home health aide visits for Patient #4 were not conducted on the following dates: 02/05/2024 through 02/09/2024. The record failed to evidence missed visit reports or MD notification for the missed visits from 02/05/2024 through 02/09/2024. These records were requested from the office manager on 02/27/2024 and 02/29/2024. 3. A review of the clinical record for Patient #6 revealed a Home Health Certification and Plan of Care document for the certification period of 02/03/2024 – 04/02/2024 which evidenced diagnoses but not limited to Type 2 diabetes mellitus (a long-term condition in which the body has trouble controlling blood sugar and using it for energy). Mental/Cognitive Status Oriented x 3, Depressed. Patient #6 was to received HHA (home health services) 5 times a week for 9 weeks up to 8 hours a day. A review of HHA visit notes evidenced home health aide visits for Patient #4 were not conducted on the following dates: 01/30/2024 and 02/06/2024. A review of the clinical record for Patient #6 indicated a nursing supervisory visit was conducted on 02/06/2024 by RN 1 at 4:15 PM. RN 1 indicated on the document that the HHA was not present. There was a HHA visit note documented by HHA 19 dated 02/06/2024 with a clock in time of 3:58 PM and a clock out time of 12 AM. On 02/26/2024 at 11 AM, Patient #6 indicated they do not receive any services in the evening, the only service they get is from 8 AM to 4 PM, Monday through Friday, then asked this writer if they were eligible for evening hours. 4. On 02/26/2024 at 11:49 AM, when queried about the supervisory visit conducted on 02/06/2024, RN 1 indicated that if they marked on the supervisory visit that an HHA wasn’t present, then they weren’t present. A review of the clinical record failed to evidence communication/missed visit notes or MD notification of missed visits. 5. A review of the clinical record for Patient #8 revealed a Home Health Certification and Plan of Care document for the certification period of 01/25/2024 – 03/24/2024 which evidenced diagnoses but not limited to Type 2 diabetes mellitus (a long-term condition in which the body has trouble controlling blood sugar and using it for energy) with diabetic chronic kidney disease (a decrease in kidney function that occurs in some people who have diabetes which means that your kidneys are not doing their job as well as they once did to remove waste products and excess fluid from your body and these wastes can build up in your body and cause damage to other organs) and end-stage renal disease (a person’s kidneys cease to function permanently leading to the need for regular course of long-term dialysis [the process of removing excess water, solutes, and toxins from the blood in people whose kidneys can no longer perform these functions naturally] or a kidney transplant), and legal blindness, as defined in USA. Mental/Cognitive Status Oriented x 3, Forgetful Caregiver Status: Patient is blind, lives in residential home and has 24 hours supervision, makes own decisions. Psychosocial Status: Barriers to Heath Status (Multiple co-morbidities, Multiple health providers, Other (Blind) Comments: Patient is legally blind and requires max assist of another person for safety to prevent falls. Patient #8 was to receive SN (skilled nursing) 1 time a month for 2 months, PT (Physical Therapy) 2 times a week for 9 weeks, and HHA (home health aides) 7 times a week for 9 weeks. A review of the clinical record for Patient #8 revealed a document titled ‘STATE HHA CARE PLAN’ (a plan for home health aides to follow for the patient) revealed Patient #8 was to receive HHA (home health aide) services 5-7 times a week for 9 weeks. A review of HHA visit notes evidenced home health aide visits were not conducted on the following dates: 01/28/2024 and 02/18/2024. The record failed to evidence missed visit reports or MD notification for the missed visits on 01/28/2024 and 02/18/2024. 6. On 02/27/2024 at 9:54 AM during an interview with HHA 4 (the scheduler for the agency and Entity U) indicated they review the charting every day, talk to the patients every day, look at every record to ensure visits are being completed as ordered. On 02/28/2024 at 10:39 AM, the clinical manager indicated when any visits are missed, an order is sent to the MD and a communication note is put in the record. We do try to staff if at all possible. On 02/29/2024 at 12:52 PM, the administrator indicated they would be calling the patient’s physician to notify of missed visits, speak with the scheduler to find out why visits aren’t happening, and try to fix it. 7. Review of the electronic clinical record for Patient #3 evidenced a Start of Care date of 06-20-2023 and a Plan of Care dated 02-12-2024 for the certification period of 02-15-2024 through 4-14-2024, contained diagnoses which included, but were not limited to: Diabetes Mellitus (blood glucose, or blood sugar, levels are too high), Hemiplegia (brain damage or spinal cord injury which leads to paralysis on one side of the body, causing weakness, problems with muscle control, and muscle stiffness with degrees of symptoms varying) following cerebral infarction (ischemic stroke, occurs as a result of disrupted blood flow to the brain due can cause parts of the brain to die off) affecting non-dominant left side, long term use of insulin, acquired absence of right leg below the knee, acquired absence of left toes, dependence on wheelchair, history of falling. The plan of care included a medication list which included but was not limited to: “HUMALOG (a fast-acting, mealtime insulin used to control high blood sugar in individuals with diabetes) KWIKPEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 44 units by subcutaneous route every day as per sliding scale subcutaneous (SQ)” and, “LANTUS (a long-acting insulin which starts to work about 2 hours after injection and lasts for up to 24 hours to maintain normal blood sugar levels) SOLOSTAR PEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 50 units subcutaneous route 2 times every day subcutaneous”, the record failed to evidence a sliding scale for the Humalog insulin. The plan of care indicated the patient was to receive Skilled Nursing every 30 days for supervisory visits and one (1) time every 56-60 days for Home Health Care Recertification, and Home Health Aide services five (5) times per week, “up to 8 hours per day” for safety with ADLS, IADLS, personal hygiene, grooming, medication reminders, light housekeeping, and meal prep. The 60-day summary indicated, “… Denies fall, injury, ED visits or hospitalizations or medication concerns this home health episode … plan of care reviewed with patient, patient in agreement with plan and denies any need for changes at this time …” A section titled ‘Nursing’ contained the following nursing interventions, “… Patient assessed to be at high risk for emergency department visit and/or hospital readmission. All necessary interventions to address the underlying risk factors are as follows: SN to minimize/eliminate risk for hospitalization due to problems associated with physical limitations … SN to assess and instruct patient on mitigation of hospital risks: due to problems associated with: polypharmacy/high risk medications: DM, PVD, physical limitations: poor health literacy and patient support …” and failed to evidence patient-specific details. In a section titled ‘Risk Factors’ stated, “… SN to assess diabetic status, identify any signs or symptoms of impaired diabetic function, report significant changes to physician … SN to instruct on self-management program to include, disease process, who to contact if signs and symptoms persist or worsen as well as dietary measures, medication management, foot care precautions, blood sugar monitoring, hypo/hyperglycemia management and long term complications … SN to prepare/teach patient/caregiver to administer insulin [dosage and frequency] using aseptic technique … SN to perform medication review each skilled nursing visit and reconcile medications as indicated. SN to instruct on all new and changed medications and reinforce teaching related to use of medications a part of disease process or demonstrated knowledge deficit …” A section titled, ‘Goals’ stated, “… Patient will demonstrate compliance with medication regimen as evidenced by correct administration, reporting side effects or adverse reactions by EOE [end of episode]. Patient will demonstrate ability to effectively manage medication regimen by EOE … Patient will demonstrate competence with self-management of DM [Diabetes Mellitus] as evidenced by adherence to the medication regimen, ability to identify s/s necessitating contact with medical professionals, diet regimen guidelines, activity compliance and symptom management by EOE …” The record failed to evidence the agency had identified the patient’s care needs required more than intermittent services, failed to detail how the patient’s specific functional impairments: poor manual dexterity related to the patient’s absence of fingers of the right hand, cognitive impairment, recent vision correction surgery, and lack of family/caregiver availability or support, collectively affected the patient’s ability to care for themselves and their needs and failed to ensure additional, regular, and frequent Skilled Nursing visits were ordered to address the education, teaching, and interventions outlined in the plan of care. Review of the paper clinical record for Patient #3 evidenced an order from Doctor I’s office dated 09-20-2023 which stated, “… Referrals; Home Health Evaluate and treat … Clinical Indications/Reason for Referral: insulin administration/medication management …” On 02-28-2024 at 11:34 AM, in a telephone interview regarding Patient #3 with Person J, of Doctor I’s office, indicated the intent of home health services was home care nursing would provide insulin administration and management. Was unaware patient was not receiving these services. Indicated the patient had “cognitive deficits for sure”. On 02-29-2024 at 9:50 AM, in an interview with the Clinical Supervisor, indicated had not ever seen the paper document with the physician’s order for nursing to provide insulin administration and medication management and was surprised to learn the agency had this document in their possession since September of 2023 Indicated if the order had been seen, “we would have been providing that for [Patient #3]” and indicated would be contacting the physician and asking for daily visits now, if not three times a day, and indicated they had staff who could cover this. On 03-05-2024 at 12:08 PM the Administrator, after reviewing the record for Patient #3, indicated was, “not sure why nursing wasn’t ordered” for the patient. 1. Review of an agency document, revised April 2019, titled PATIENT BILL OF RIGHTS Policy No. 2-002’ revealed, “ … PURPOSE To encourage awareness of patient rights and provide guidelines to assist patients in making decisions regarding care and for active participation in care planning. … PROCDURE … H. The completion of all assessments and care to be furnished, based on the comprehensive assessment. The organization shall ensure that the patient receives all services outlined in the plan of care … “ Review of an agency document, revised April 2019, titled ‘CARE PLANNING PROCESS Policy No. 4-001’ stated, “PURPOSE To provide direction to the clinicians providing direct patient care ... PROCEDURE ... the clinician ... will develop the plan of care based on the patient’s identified needs and will review it with the patient and family/caregiver. 2. All clinicians will consider their conclusions of initial and ongoing assessments in their care planning process including, but not limited to: A. Individualized patient needs and resultant problems related to care, functional status, and family/caregiver support system. 3. Based on the assessment and conclusions, the plan of care will include but not be limited to: ... B. Identified patient problems and needs ... D. Specific services and treatments to be provided ... F. Type, frequency, and duration of above actions ... “ . 2. A review of the clinical record for Patient #4 revealed a Home Health Certification and Plan of Care document for the certification period of 01/25/2024 – 03/24/2024 which evidenced diagnoses but not limited Cerebral Palsy (a group of disorders which affect a person’s ability to move and maintain balance and posture. Cerebral means having to do with the brain and palsy means weakness or problems with using the muscle[s]). Patient #4 was to receive HHA (home health services) 5 times a week for 9 weeks up to 8 hours a day. A review of the clinical record for Patient #4 revealed a document titled ‘STATE HHA CARE PLAN’ (a plan for home health aides to follow for the patient) revealed Patient #4 was to receive HHA (home health aide) services 5 times a week for 9 weeks. A review of HHA visit notes evidenced home health aide visits for Patient #4 were not conducted on the following dates: 02/05/2024 through 02/09/2024. The record failed to evidence missed visit reports or MD notification for the missed visits from 02/05/2024 through 02/09/2024. These records were requested from the office manager on 02/27/2024 and 02/29/2024. 3. A review of the clinical record for Patient #6 revealed a Home Health Certification and Plan of Care document for the certification period of 02/03/2024 – 04/02/2024 which evidenced diagnoses but not limited to Type 2 diabetes mellitus (a long-term condition in which the body has trouble controlling blood sugar and using it for energy). Mental/Cognitive Status Oriented x 3, Depressed. Patient #6 was to received HHA (home health services) 5 times a week for 9 weeks up to 8 hours a day. A review of HHA visit notes evidenced home health aide visits for Patient #4 were not conducted on the following dates: 01/30/2024 and 02/06/2024. A review of the clinical record for Patient #6 indicated a nursing supervisory visit was conducted on 02/06/2024 by RN 1 at 4:15 PM. RN 1 indicated on the document that the HHA was not present. There was a HHA visit note documented by HHA 19 dated 02/06/2024 with a clock in time of 3:58 PM and a clock out time of 12 AM. On 02/26/2024 at 11 AM, Patient #6 indicated they do not receive any services in the evening, the only service they get is from 8 AM to 4 PM, Monday through Friday, then asked this writer if they were eligible for evening hours. 4. On 02/26/2024 at 11:49 AM, when queried about the supervisory visit conducted on 02/06/2024, RN 1 indicated that if they marked on the supervisory visit that an HHA wasn’t present, then they weren’t present. A review of the clinical record failed to evidence communication/missed visit notes or MD notification of missed visits. 5. A review of the clinical record for Patient #8 revealed a Home Health Certification and Plan of Care document for the certification period of 01/25/2024 – 03/24/2024 which evidenced diagnoses but not limited to Type 2 diabetes mellitus (a long-term condition in which the body has trouble controlling blood sugar and using it for energy) with diabetic chronic kidney disease (a decrease in kidney function that occurs in some people who have diabetes which means that your kidneys are not doing their job as well as they once did to remove waste products and excess fluid from your body and these wastes can build up in your body and cause damage to other organs) and end-stage renal disease (a person’s kidneys cease to function permanently leading to the need for regular course of long-term dialysis [the process of removing excess water, solutes, and toxins from the blood in people whose kidneys can no longer perform these functions naturally] or a kidney transplant), and legal blindness, as defined in USA. Mental/Cognitive Status Oriented x 3, Forgetful Caregiver Status: Patient is blind, lives in residential home and has 24 hours supervision, makes own decisions. Psychosocial Status: Barriers to Heath Status (Multiple co-morbidities, Multiple health providers, Other (Blind) Comments: Patient is legally blind and requires max assist of another person for safety to prevent falls. Patient #8 was to receive SN (skilled nursing) 1 time a month for 2 months, PT (Physical Therapy) 2 times a week for 9 weeks, and HHA (home health aides) 7 times a week for 9 weeks. A review of the clinical record for Patient #8 revealed a document titled ‘STATE HHA CARE PLAN’ (a plan for home health aides to follow for the patient) revealed Patient #8 was to receive HHA (home health aide) services 5-7 times a week for 9 weeks. A review of HHA visit notes evidenced home health aide visits were not conducted on the following dates: 01/28/2024 and 02/18/2024. The record failed to evidence missed visit reports or MD notification for the missed visits on 01/28/2024 and 02/18/2024. 6. On 02/27/2024 at 9:54 AM during an interview with HHA 4 (the scheduler for the agency and Entity U) indicated they review the charting every day, talk to the patients every day, look at every record to ensure visits are being completed as ordered. On 02/28/2024 at 10:39 AM, the clinical manager indicated when any visits are missed, an order is sent to the MD and a communication note is put in the record. We do try to staff if at all possible. On 02/29/2024 at 12:52 PM, the administrator indicated they would be calling the patient’s physician to notify of missed visits, speak with the scheduler to find out why visits aren’t happening, and try to fix it. 7. Review of the electronic clinical record for Patient #3 evidenced a Start of Care date of 06-20-2023 and a Plan of Care dated 02-12-2024 for the certification period of 02-15-2024 through 4-14-2024, contained diagnoses which included, but were not limited to: Diabetes Mellitus (blood glucose, or blood sugar, levels are too high), Hemiplegia (brain damage or spinal cord injury which leads to paralysis on one side of the body, causing weakness, problems with muscle control, and muscle stiffness with degrees of symptoms varying) following cerebral infarction (ischemic stroke, occurs as a result of disrupted blood flow to the brain due can cause parts of the brain to die off) affecting non-dominant left side, long term use of insulin, acquired absence of right leg below the knee, acquired absence of left toes, dependence on wheelchair, history of falling. The plan of care included a medication list which included but was not limited to: “HUMALOG (a fast-acting, mealtime insulin used to control high blood sugar in individuals with diabetes) KWIKPEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 44 units by subcutaneous route every day as per sliding scale subcutaneous (SQ)” and, “LANTUS (a long-acting insulin which starts to work about 2 hours after injection and lasts for up to 24 hours to maintain normal blood sugar levels) SOLOSTAR PEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 50 units subcutaneous route 2 times every day subcutaneous”, the record failed to evidence a sliding scale for the Humalog insulin. The plan of care indicated the patient was to receive Skilled Nursing every 30 days for supervisory visits and one (1) time every 56-60 days for Home Health Care Recertification, and Home Health Aide services five (5) times per week, “up to 8 hours per day” for safety with ADLS, IADLS, personal hygiene, grooming, medication reminders, light housekeeping, and meal prep. The 60-day summary indicated, “… Denies fall, injury, ED visits or hospitalizations or medication concerns this home health episode … plan of care reviewed with patient, patient in agreement with plan and denies any need for changes at this time …” A section titled ‘Nursing’ contained the following nursing interventions, “… Patient assessed to be at high risk for emergency department visit and/or hospital readmission. All necessary interventions to address the underlying risk factors are as follows: SN to minimize/eliminate risk for hospitalization due to problems associated with physical limitations … SN to assess and instruct patient on mitigation of hospital risks: due to problems associated with: polypharmacy/high risk medications: DM, PVD, physical limitations: poor health literacy and patient support …” and failed to evidence patient-specific details. In a section titled ‘Risk Factors’ stated, “… SN to assess diabetic status, identify any signs or symptoms of impaired diabetic function, report significant changes to physician … SN to instruct on self-management program to include, disease process, who to contact if signs and symptoms persist or worsen as well as dietary measures, medication management, foot care precautions, blood sugar monitoring, hypo/hyperglycemia management and long term complications … SN to prepare/teach patient/caregiver to administer insulin [dosage and frequency] using aseptic technique … SN to perform medication review each skilled nursing visit and reconcile medications as indicated. SN to instruct on all new and changed medications and reinforce teaching related to use of medications a part of disease process or demonstrated knowledge deficit …” A section titled, ‘Goals’ stated, “… Patient will demonstrate compliance with medication regimen as evidenced by correct administration, reporting side effects or adverse reactions by EOE [end of episode]. Patient will demonstrate ability to effectively manage medication regimen by EOE … Patient will demonstrate competence with self-management of DM [Diabetes Mellitus] as evidenced by adherence to the medication regimen, ability to identify s/s necessitating contact with medical professionals, diet regimen guidelines, activity compliance and symptom management by EOE …” The record failed to evidence the agency had identified the patient’s care needs required more than intermittent services, failed to detail how the patient’s specific functional impairments: poor manual dexterity related to the patient’s absence of fingers of the right hand, cognitive impairment, recent vision correction surgery, and lack of family/caregiver availability or support, collectively affected the patient’s ability to care for themselves and their needs and failed to ensure additional, regular, and frequent Skilled Nursing visits were ordered to address the education, teaching, and interventions outlined in the plan of care. Review of the paper clinical record for Patient #3 evidenced an order from Doctor I’s office dated 09-20-2023 which stated, “… Referrals; Home Health Evaluate and treat … Clinical Indications/Reason for Referral: insulin administration/medication management …” On 02-28-2024 at 11:34 AM, in a telephone interview regarding Patient #3 with Person J, of Doctor I’s office, indicated the intent of home health services was home care nursing would provide insulin administration and management. Was unaware patient was not receiving these services. Indicated the patient had “cognitive deficits for sure”. On 02-29-2024 at 9:50 AM, in an interview with the Clinical Supervisor, indicated had not ever seen the paper document with the physician’s order for nursing to provide insulin administration and medication management and was surprised to learn the agency had this document in their possession since September of 2023 Indicated if the order had been seen, “we would have been providing that for [Patient #3]” and indicated would be contacting the physician and asking for daily visits now, if not three times a day, and indicated they had staff who could cover this. On 03-05-2024 at 12:08 PM the Administrator, after reviewing the record for Patient #3, indicated was, “not sure why nursing wasn’t ordered” for the patient.”

“Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s internal policies. (4) When services are provided on the basis of a physician or allowed practitioner’s verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA’s policies, must document the orders in the patient’s clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA’s internal policies. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure verbal orders were signed and dated by the nurse or qualified clinician responsible for furnishing or supervising the ordered services in 3 of 8 active records reviewed. (Patients #5, 6, and 8) Findings include: 1. A review of an agency policy, revised April 2019, titled ‘VERIFICATION OF PHYSICIAN ORDERS’ Policy No. 4-003.1 revealed “PURPOSE To ensure that accurate physician … orders are obtained in accordance with applicable law and regulation … POLICY … Verbal orders will be spoken to, taken and documented only by professional, licensed home health personnel (RN or qualified therapist) A qualified individual will review each order … PROCEDURE … 2. All telephone orders will be received and processed in accordance with state and federal laws and regulations. 3. All telephone orders or verbal orders will be “read back” to the physician … “ 2. A review of the clinical record for Patient #5 revealed a document titled ‘Physician Order’ to Person CC for Patient #5 dated 02/07/2024 for a verbal order for recertification for ongoing home health care needs. The record failed to evidence the signatures of the clinician, physician, and whom the clinician spoke with. 3. A review of the clinical record for Patient #6 revealed a document titled ‘Physician Order’ to Person Y, the physician for Patient #6 dated 01/31/2024 at 4:45, indicated it was a voice order which was received to recertify Patient #6 for home health care services, the order was read back and verified which failed to evidence the clinician writing the order. 4. A review of the clinical record for Patient #8 revealed a document titled ‘Physician Order’ to Person T the physician for Patient #8 for a Physical Therapy re-evaluation order for a frequency change: Physical Therapy: 2 times a week for 4 weeks, effective 02/06/2024, received physical therapy re-evaluation order for continued services, indicated the order was read back and verified but failed to evidence a clinician signature, or whom they spoke with at the physicians office, dated 02/06/2024 and at 2:30 PM. 5. On 02/29/2024 at 12:50 PM, the Clinical Supervisor indicated had not been documenting who they speak to at physicians’ offices when obtaining verbal orders. On 03/05/2024 at 10:30 AM, the Administrator indicated the office manager (non-clinical) used to obtain verbal orders for the agency. 410IAC 17-14-1(a)(H)”

“Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure the plan of care was reviewed by the attending physician every 60 days in 1 of 8 active record reviews. (Patient #5) Findings include: 1. A review of an agency policy, revised April 2019, titled ‘CARE PLANNING PROCESS’ Policy No. 4-001.1-.5 revealed “PURPOSE To provide clinical direction to the clinicians providing direct care … plan of care … updated at least every 60 days or as patient’s condition warrants … “ 2. A review of an agency policy, revised April 2019, titled ‘PHYSICIAN PARTICIPATION IN PLAN OF CARE’ Policy No. 4-002.1-.3 revealed PURPOSE To provide guidelines for the physician’s participation in home health care services … “ 3. A review of the clinical record for Patient #5 revealed a Home Health Certification and Plan of Care document for the certification period of 02/03/2024 – 04/02/2024 which evidenced the attending physician was Person CC. 4. On 03/04/2024 at 9:59 AM this writer phoned Entity S to interview CC and to request copies of medications, the physician listed on the plan of care (POC), Person EE indicated Patient #5 was not a patient at that clinic. 5. On 03/05/2024 at 3:38 PM, the clinical manager indicated Patient #5 is being followed by Person DD, a physician. The clinical manager indicated they thought they had changed the physician in the record and indicated that Person DD had been following Patient #5 for a couple of months. 410IAC 17-13-1(a)(2)”

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure the physician was notified of patient change in condition, for 2 of 8 active records reviewed. (Patient #3 and Patient #9) Findings include: 1. Review of an agency document revised April 2019, titled ‘MONITORING PATIENT RESPONSE/REPORTING TO PHYSICIAN Policy No. 4-012’ stated, “… The patient’s physician will be contacted on the same day when any of the following occur. A. Significant changes in the patient’s condition …” Review of an agency document revised April 2019, titled ‘REASSESSMENTS/RECERTIFICATION Policy No. 4-020’ stated, “… Changes that have occurred regarding diagnosis, prognosis, or treatment (including procedures, medications, precautions, and limitations) ... when: … There is a significant change in the patient’s condition, care environment and/or support system B. Transfer of a patient to an inpatient facility C. The patient returns home after an inpatient admission lasting 24 hours or longer for any purpose other than diagnostic testing … 5. The physician will be notified of any of the above situations …” 2. Review of the electronic record clinical record for Patient #3 failed to evidence communication had been made to the physician regarding the patient’s ER visit on 01-12-2024. On 02-28-2024 at 11:34 AM, in a telephone interview regarding Patient #3 with Person JJ, of Doctor I’s office, indicated had been aware the patient was hospitalized on 1-12-2024 because they could see the patient’s home from the office and saw the day the ambulance was there, not because the agency informed them of the Emergency Room visit. Indicated had not received any telephone communication from A Passionate Helping Hand since March of 2023. On 02-29-2024 at 2:26 PM, in an interview with the Clinical Supervisor, was unaware Patient #3 had an amputation of the right fifth digit during his time under the agency’s care, was unaware the patient had undergone vision correction surgery and was unaware of the patient’s recent fall which led to an ER visit on 01-12-2024 and indicated the aide does not relay everything to her. On 02-29-2024 at 3:29 PM, the Clinical Supervisor, after verifying for Patient #3, there were no skilled nursing visits done “at all”, just the Recert. 3. Review of the electronic clinical record for Patient #9 failed to evidence communication had been made to the physician regarding the patient’s hospitalization on 02-20-2024. On 03-04-2024 at 11:45 AM, when queried as to whether the agency had notified them Patient #9 had been hospitalized recently, Person II with Doctor HH indicated they only found out because the hospital pharmacist had contacted them, not because the home health agency had notified them. 410 IAC 17-13-1(a)(2)”

“Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient’s needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure care coordination occurred between the agency and other service providers in 2 of 8 active records reviewed. (Patients #6 and 8) Findings include: 1. A review of an agency’s policy dated revised April 2019 titled, ‘COORDINATION OF SERVICES WITH OTHER PROVIDERS’ Policy No. 4-016.1 revealed PURPOSE to ensure the coordination of services provided by the organization and by other service providers … 3. The case manager will be responsible for the coordination between service providers, which will include … C. Monitoring duplication or conflict of services provided by various organizations … “ 2. A review of the clinical record for Patient #6 revealed a Home Health Certification and Plan of Care document for the certification period of 02/03/2024 – 04/02/2024 which evidenced diagnoses but not limited to Type 2 diabetes mellitus (a long-term condition in which the body has trouble controlling blood sugar and using it for energy). Mental/Cognitive Status Oriented x 3, Depressed. Patient #6 was to receive HHA (home health services) 5 times a week for 9 weeks up to 8 hours a day. On 02/26/2024 at 9:50 AM the administrator indicated Patient # 6 received services from Entity U, an agency that provides attendant care services. The record failed to evidence care coordination with Entity U. 3. A review of the clinical record for Patient #8 revealed a Home Health Certification and Plan of Care document for the certification period of 01/25/2024 – 03/24/2024 which evidenced Patient #8 was to receive SN (skilled nursing) 1 time a month for 2 months, PT (Physical Therapy) 2 times a week for 9 weeks, and HHA (home health aides) 7 times a week for 9 weeks. On 02/26/2024 at 9:50 AM, the administrator indicated Patient #8 received services from Entity U. The record failed to evidence care coordination with Entity U. 4. On 02/26/2024 at 2:53 PM, the administrator indicated for care coordination, the agency would contact any other entity providing services for the patients, find out hours so there would be no duplication of services, and further indicated the clinical manager is responsible for ensuring other providers are aware of services the agency is providing, this would all be documented on the plan of care, communication notes or coordination of care note. 410 IAC 17-14-1(a)(1)(F) 410 IAC 17-14-2(g) 410 IAC 17-14-1(c)(6)”

“Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This Element is not met as evidenced by: Based on observation, record review, and interview the agency failed to ensure patients received a copy of their visit schedules in 2 of 3 home visits. (Patients #3 and 4) Findings include: 4. On 2-23-2024 at 9:30 AM during a home visit with Patient # 3, a patient with a history of dementia (an impairment of memory) and an individual with no legal power of attorney (POA), who lived alone, no folder/binder containing a copy of the proposed visit schedule from the agency was found in the patient’s home and when queried the patient could not determine where it would be, or if they had ever had one, and indicated HHA 1 might know. 1. A review of an agency’s policy titled, ‘CARE PLANNING PROCESS’ Policy no. 4-001.1-.5 Revised April 2009 revealed, “PURPOSE To provide clinical direction to the clinicians providing direct patient care … PROCEDURE … 16. The organization shall provide the patient and caregiver with a copy of written instructions outlining: A. Visit schedule … “ 2. During a home visit on 02/23/2024 at 9:31 AM to observe HHA 1 provide home health aide services for Patient #4, after knocking on Patient #4 door and no answer, found HHA 1in an unoccupied apartment and Patient #4 in the doorway of the apartment. Patient #4 and this writer returned to their apartment, this writer asked to see the binder from the agency, Patient #4 retrieved the binder from the closet. The binder failed to evidence a schedule. This writer queried Patient #4 if they ever received a schedule, and they indicated no, they’ve never received anything from the agency other than that binder. 3. On 02/29/2024 at 12:54 PM, the administrator indicated they didn’t realize a visit schedule was required to be in the patient’s home.”

“Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This Element is not met as evidenced by: Based on observation, record review, and interview the agency failed to ensure patients received a copy of their medication lists in 2 of 3 home visits. (Patients #3 and 4) Findings include: 4. On 2-23-2024 at 9:30 AM during a home visit with Patient # 3, a patient with a history of dementia (an impairment of memory) and an individual with no legal power of attorney (POA), who lived alone, no folder/binder containing the patients medication list from the agency was found in the patient’s home and when queried the patient could not determine where it would be, or if they had ever had one, and indicated HHA 1 might know. 1. A review of an agency’s policy titled, ‘CARE PLANNING PROCESS’ Policy no. 4-001.1-.5 Revised April 2009 revealed, “PURPOSE To provide clinical direction to the clinicians providing direct patient care … PROCEDURE … 16. The organization shall provide the patient and caregiver with a copy of written instructions outlining: … B. Patient medication schedule/instructions … “ 2. During a home visit on 02/23/2024 at 9:31 AM to observe HHA 1 provide home health aide services for Patient #4, after knocking on Patient #4 door and no answer, found HHA 1in an unoccupied apartment and Patient #4 in the doorway of the apartment. Patient #4 and this writer returned to their apartment, this writer asked to see the binder from the agency, Patient #4 retrieved the binder from the closet. The binder failed to have a medication list. This writer queried Patient #4 if they ever received a medication list, and they indicated no, they’ve never received anything from the agency but the binder. 3. On 02/29/2024 at 12:54 PM, the administrator indicated they didn’t realize a medication schedule/list was required to be in the home.”

“Other pertinent instructions CFR(s): 484.60(e)(4) Any other pertinent instruction related to the patient’s care and treatments that the HHA will provide, specific to the patient’s care needs. This Element is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure patients received a copy of the plan of care in 2 of 3 home visits conducted. (Patient #3 and 4) Findings include: 4. On 2-20-2024 at 9:00 AM during a home visit with Patient # 3, a patient with a history of dementia (an impairment of memory) and an individual with no legal power of attorney (POA), who lived alone, no folder/binder from the agency was found in the patient’s home and when queried the patient could not determine where it would be, or if they had ever had one, and indicated HHA 1 might know. 1. A review of an agency’s policy titled, ‘CARE PLANNING PROCESS’ Policy no. 4-001.1-.5 Revised April 2009 revealed, “PURPOSE To provide clinical direction to the clinicians providing direct patient care … PROCEDURE … 16. The organization shall provide the patient and caregiver with a copy of written instructions outlining: … D. Any other pertinent instruction related to the patient’s care and treatments … specific to the patient’s care needs … “ 2. During a home visit on 02/23/2024 at 9:31 AM to observe HHA 1 provide home health aide services for Patient #4, after knocking on Patient #4 door and no answer, found HHA 1in an unoccupied apartment and Patient #4 in the doorway the apartment. Patient #4 and this writer returned to their apartment, Patient #4 indicated HHA 1 assists Patient #1 with bathing and cleaning their apartment. This writer asked to see the binder from the agency, Patient #4 retrieved the binder from the closet. The binder failed to evidence a plan of care. I queried Patient #4 if they ever received a plan of care, and they indicated no, they’ve never received anything from the agency but that binder. 3. On 02/29/2024 at 12:54 PM, the administrator indicated they didn’t realize a plan of care was required to be in the patient’s home.”

“Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This Element is not met as evidenced by: Based on observation, record review, and interview the Skilled Professional Nurse failed in their responsibility to ensure the Plan of Care was developed and evaluated with the patient/caregiver/representative’s participation, in 1 of 3 home visits observed. (Patient #3) Findings include: Review of an agency document revised April 2019, titled ‘PATIENT EDUCATION PROCESS Policy No. 4-049’ stated, “… POLICY Patients and family/caregivers will receive education in verbal, visual, and written form, as appropriate. The scope of teaching will be determined by assessing the needs, abilities, learning preferences, and readiness to learn of the patient and family/caregiver, as well as by the plan of care, goal and established outcomes … PROCEDURE 1. The clinician will assess, plan, implement, and evaluate the following on each patient and family/caregiver, as appropriate: … D. The ability and readiness of the patient and family/caregiver to learn … H. Physical and/or cognitive limitations, as well as communication and language barriers to learning … 2. Based on the above, the assessments will be used as the basis, for planning patient and family/caregiver education. In the event that any barriers to learning exist, these barriers, as appropriate, will be discussed with the patient and family/caregiver as well as the Clinical Supervisor. If they cannot be overcome, the patient’s physician will be contacted … 5. If a patient lives alone and there is no one able or willing to receive the instruction, the physician will be informed, and this information will be documented in the clinical record. 6. Unless otherwise ordered by the physician (or other authorized licensed independent practitioner), the patient and family/caregiver will receive verbal and, as appropriate, written instructions that are in plain language …” Review of an agency document, revised April 2019, titled ‘CARE PLANNING PROCESS Policy No. 4-001’ stated, “PURPOSE To provide direction to the clinicians providing direct patient care ... PROCEDURE ... the clinician ... will develop the plan of care based on the patient’s identified needs and will review it with the patient and family/caregiver. 2. All clinicians will consider their conclusions of initial and ongoing assessments in their care planning process including, but not limited to: A. Individualized patient needs and resultant problems related to care, functional status, and family/caregiver support system ...” Review of an agency document, revised April 2019, titled ‘PATIENT BILL OF RIGHTS Policy No. 2-002’ stated, “… PURPOSE To encourage awareness of patient rights and provide guidelines to assist patients in making decisions regarding care and for active participation in care planning …” Review of the electronic clinical record for Patient #3 evidenced a Plan of Care dated 02-12-2024 for the certification period of 02-15-2024 through 4-14-2024 and contained diagnoses which included, but were not limited to: Diabetes Mellitus (blood glucose, or blood sugar, levels are too high), Hemiplegia (brain damage or spinal cord injury that leads to paralysis on one side of the body, causing weakness, problems with muscle control, and muscle stiffness with degrees of symptoms varying) following cerebral infarction (ischemic stroke, occurs as a result of disrupted blood flow to the brain, the lack of adequate blood supply to brain cells deprives them of oxygen, can cause parts of the brain to die off) affecting non-dominant left side, long term use of insulin, acquired absence of right leg below the knee, acquired absence of left toes, dependence on wheelchair, history of falling. The plan of care contained a medication list which included but was not limited to: “HUMALOG (a fast-acting, mealtime insulin used to control high blood sugar in individuals with diabetes) KWIKPEN 100 UNITS/ML SUBCUTANEOUS (intended for injection given in the fatty tissue, just under the skin) SOLUTION 30 Inject 44 units by subcutaneous route every day as per sliding scale (varies the dose of insulin based on blood glucose level, the higher your blood glucose the more insulin you take, this method is more precise than fixed dose insulin) subcutaneous (SQ)” and, “LANTUS (a long-acting insulin that starts to work about 2 hours after injection and lasts for up to 24 hours to maintain normal blood sugar levels) SOLOSTAR PEN 100 UNITS/ML SUBCUTANEOUS SOLUTION 30 Inject 50 units subcutaneous route 2 times every day subcutaneous”. The record failed to evidence a sliding scale. The plan of care ordered Skilled Nursing every 30 days for supervisory visits and one (1) time every 56-60 days for Home Health Care Recertification only, and ordered Home Health Aide services 5 times per week, “up to 8 hours per day” for safety with ADLS, IADLS, personal hygiene, grooming, medication reminders, light housekeeping, and meal prep. The 60-day summary indicated, “… Denies fall, injury, ED visits or hospitalizations or medication concerns this home health episode … plan of care reviewed with patient, patient in agreement with plan and denies any need for changes at this time …” Section titled ‘Risk Factors’ indicated, “… SN to prepare/teach patient/caregiver to administer insulin [dosage and frequency] using aseptic technique … SN to perform medication review each skilled nursing visit and reconcile medications as indicated. SN to instruct on all new and changed medications and reinforce teaching related to use of medications a part of disease process or demonstrated knowledge deficit …” The plan of care failed to evidence the skilled nurse had appropriately evaluated and developed a plan with a patient who had notable cognitive deficits, failed to identify how their functional and psychosocial impairments: the extent of cognitive deficits and lack of family/caregiver availability or support, collectively affected the patient’s ability to make care decisions for themselves and provide for their own needs. The document also failed to evidence the skilled nurse had inquired regarding an emergency contact, next of kin, Power of Attorney (POA), or other guardianship and failed to evidence that contact had been made or attempted with other outside resources to assist in making such arrangements or determinations. Review of an outside hospital document dated 01-12-2024, detailed Patient #3’s visit to the Emergency Room related to a fall, elevated Blood Sugar reading of 468 mg/dl, general weakness, and cellulitis of the left lower extremity. The document evidenced a diagnosis of dementia, and the patient had been released home with antibiotics. On 2-20-2024 at 9:00 AM during a home visit with Patient # 3, the patient was found to be alone in their apartment. Memory deficits were apparent, patient asked similar questions multiple times (i.e. “Would you like a drink?”, “Do you live around here?”, “Would you like a seat?”), despite having been answered moments previously. The patient presented with a right below-the-knee amputation and left toes were amputated, fingers to the right hand had been amputated. Indicated was learning to use their left hand to write their signature. Was able to hold a cell phone with the right hand. The patient transferred themselves from their bed to their electric wheelchair. When queried as to whether the patient had their insulin yet today and how the patient receives their insulin, indicated “[Home Health Aide {HHA} #1] will give me my shots”, and indicated this twice. On 02-26-2024 at 3:22 PM when queried as to whether Patient #3 had cognitive issues, the Clinical Supervisor indicated, “yes” they did. When queried as to whether the patient had next of kin/guardian/county resource case manager, the Administrator asked the Clinical Supervisor if the agency had not figured out guardianship for the patient, the office manager indicated knew of care manager with a waiver program and offered the contact info. When queried as to whether the patient ought to be making his own decisions, the Clinical Supervisor indicated the patient, “shouldn’t be”. When queried as to how consent was obtained in order to service the patient, no reply was offered. When queried as to whether the agency allowed cognitively impaired clients to sign for consent, no reply was offered. On 2-27-2024 at 3:21PM, Person MM, a care manager, with Entity LL, a Medicaid waiver program indicated Patient #3 was, “confused 95% of the time”, indicated the patient did not currently have a POA. Person MM indicated had been seeking a guardianship for the patient, and was awaiting signed paperwork from the patient’s physician for this, indicated the process will not be speedy. On 02-28-2024 at 11:34 AM, in a telephone interview regarding Patient #3 with Person J, of Doctor I’s office, indicated that the intent of home health services was for home care to provide insulin administration and management. Was unaware patient was not receiving these services. Indicate the patient had “cognitive deficits for sure”, indicated was always accompanied by HHA #1, and was not aware HHA #1 was an employee of the Home Health Agency and not a private caregiver. Indicated HHA #1 has put themselves on the patient’s list of contacts to release information to. Indicated they were aware the patient was hospitalized on 1-12-2024 because they could see the patient’s home from the office and saw the day the ambulance was there, not because the agency informed them. Indicated had not received any telephone communication from A Passionate Helping Hand Home Health since March of 2023, specifically no requests for verbal orders. Indicated however that HHA #1 had placed several calls to the physician’s office: asked for refills of medications, requested the patient’s medication list, requested a sliding scale for insulin, asked for a referral to A Passionate Helping Hand, asked for a lift chair, requested a pain management referral, asked for a different pain management referral when the first did not take the patient’s insurance, asked for a sleep study, called when the patient’s Amitriptyline was not working, requested a prescription for TED hose, asked for new Dexcom CGM (continuous glucose monitor). Person J reviewed the two insulin orders and indicated the Humalog order was not accurate, and would check into this further, as there were 44 units and a sliding scale both mentioned. Indicated the Lantus order should not be 50 units, but rather 25 units, but would clarify this further. Indicated no one from the agency had called to request the patient’s medication list and no requests had been made for copies of recent office visit notes. On 02-29-2024 at 2:26 PM, in an interview with the Clinical Supervisor, was unaware Patient #3 had an amputation of the right fifth digit during his time under the agency’s care, was unaware the patient had undergone vision correction surgery and was unaware of the patient’s recent fall which led to an ER visit on 01-12-2024, and indicated the aide does not relay everything to her. On 03-05-2024 at 12:52 PM, the Administrator and Clinical Supervisor indicated HHA #1 and #2 had called to inform Patient #3 had just been hospitalized with an infection to the left hand, elevated blood sugars, and ulcers to the left leg and left heel, believed this to be due to the way the patient’s leg rests on the prosthetic. On 03-05-2024 at 1:16 PM, the Administrator indicated if a patient, like Patient #3 required 24-hour home care, maybe they needed a skilled facility.”

“Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This Element is not met as evidenced by: Based on record review and interview the Skilled Professional Nurse failed to be responsible for ensuring Patient #9 received a timely Physical Therapy evaluation after a hospital stay for a fractured femur after being home for nine (9) days, in 1 of 8 active clinical records reviewed. (Patient #9) Findings include: 1. Review of an agency document revised April 2019, titled ‘CARE/SERVICE COORDINATION Policy No. 4-067’ stated, “PURPOSE To ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services, POLICY Each patient will be assigned a Case Manager upon admission by the Clinical Director or Clinical Supervisor. It will be the responsibility of the Case Manager to facilitate communication about changes in the patient status among assigned personnel. Timely and ongoing communication is the responsibility of each team member of the interdisciplinary group and will be appropriate to the needs and abilities of the patient, and relevant to the care/service provided. The clinician will be responsible for facilitating communications about changes in the patient’s status among the assigned personnel. 2. Review of the clinical record for Patient #9 with a start of care of 12-17-2022 evidenced an updated Plan of Care completed for a resumption on 02-26-2024 and contained diagnoses which included but were not limited to: morbid obesity (being more than 100 pounds over your ideal weight), displaced supracondylar fracture without intracondylar extension of lower end of left femur, initial (closed fracture of the femur, or the ‘thigh bone’). The Plan of Care also indicated the patient was ‘bedbound’ and ‘required total care from another person’. Skilled Nursing was ordered for 3 times per week for 6 weeks, then 1 time per week for 1 week. Home Health Aide was ordered for 5 times per week for 6 weeks, then 2 times per week for 1 week. Skilled Physical Therapy was ordered for, “1xEval” indicating an evaluation visit. The record indicated patient had returned home on 02-25-2024 after a recent hospital stay and home health services had been resumed on 02-26-2024. The plan of care stated, “02-20-2024 patient was sitting on the side of the bed, felt dizzy, syncope episode with fall, transported to ER (Emergency Room), hospital admit DX(diagnosis) Left Supracondylar FX(fracture) Femur ... patient elected nonsurgical tx(treatment) of fracture. Immobilizer in place on left leg in lieu of cast ...” Record review failed to evidence any documentation of coordination with a Physical Therapist about the Resumption of Care order. Review of the Electronic Medical Record (EMR) on 03-04-2024 failed to evidence a Physical Therapy visit had occurred. Review of a third party document dated 02-25-2024, from Entity KK, an acute care hospital, titled ‘DISCHARGE SUMMARY: FINAL REPORT’ stated, “… Discharge Orders/Instructions … Home Health Therapy Services … PT(Physical Therapy) General Assessment/Home Safety Eval … Orthopedic Trauma Discharge Instructions … Activity Restrictions & Range of Motion: Weight Bearing to your Left Lower Extremity … Range of Motion: no restrictions … Ice and elevate to help control pain and swelling …” On 03-1-2024 at 1:40 PM in a telephone interview with Patient #9, indicated needed to get ahold of the agency, had been home from the hospital since Sunday 02-25-2024, and the physical therapist had not called or visited yet. On 03-04-2024 at 9:24 PM, RN 1 indicated was aware Patient #9 was needing Physical Therapy and was aware Physical Therapy had not been out to see the patient yet. When queried as to who would make sure Physical Therapy goes out to see the patient, indicated either the office manager or they, themselves would. On 03-04-2024 at 9:48 AM, Patient #9 indicated it was their understanding the Orthopedist had ordered Physical Therapy but still had not had a visit, nor received a phone call from a Physical Therapist. On 03-04-2024 at 11:45 AM in a telephone interview with Person II of Doctor HH, when queried as to whether the agency calls for verbal orders, indicated “I used to hear from [office manager] all the time”, but not recently, and indicated did not receive calls from the agency requesting verbal orders. Indicated they are often sent faxes instead. When queried as to whether the agency had notified them Patient #9 had been hospitalized recently, indicated they only found out because the hospital pharmacist had contacted them, not because the home health agency had notified them. On 03-04-2024, a call was placed to Physical Therapist 1 but they failed to answer/respond back. On 03-05-2024 at 9:30 AM, the office manager indicated she knew that Patient #9 needed Physical Therapy and had just received orders yesterday. After updating the office manager, she indicated she did not know the orders were written on the hospital discharge paperwork. On 03-05-2024 at 3:55 PM, the Administrator indicated RN1 was making arrangements to ensure the Physical Therapist would get out to visit Patient #9 today. And indicated the responsible party was supposed to be RN 1, but RN 1 likely did not know that. 410 IAC 17-14-1(a)(1)(c) 410 IAC 17-14-(b)(2) 410 IAC 17-14-(b)(4) 410IAC 17-14-(e)(2)”

“Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure caregiver education was conducted on special nurtrtional requirements and fluid restrictions in 1 of 8 active clinical records reviewed. (Patient 8) Findings include: A review of an agency policy, revised April 2019, titled ‘HOME HEALTH AIDE PLAN OF CARE’ Policy No. 4-061.1-.2 revealed, “PURPOSE To define the process for the development and use of the home health aide plan of care ... 2. The home health aide plan of care will be individualized to the specific patient and will include at least: ... G. Nutritional requirements ... “ Review of an agency document titled ‘Job Title/Position: Clinical Supervisor’ stated, “… The Clinical Supervisor is responsible for ensuring that patient care is coordinated and managed appropriately. The Clinical Supervisor is responsible for ensuring that care and services are delivered appropriately as well as the supervision of clinical personnel … ESSENTIAL JOB FUNCTIONS/RESPONSIBILITIES … ” A review of the clinical record for Patient #8 revealed a Home Health Certification and Plan of Care document for the certification period of 01/25/2024 – 03/24/2024 which evidenced diagnoses but not limited to Type 2 diabetes mellitus (a long-term condition in which the body has trouble controlling blood sugar and using it for energy) with diabetic chronic kidney disease (a decrease in kidney function that occurs in some people who have diabetes which means that your kidneys are not doing their job as well as they once did to remove waste products and excess fluid from your body and these wastes can build up in your body and cause damage to other organs) and end-stage renal disease (a person’s kidneys cease to function permanently leading to the need for regular course of long-term dialysis [the process of removing excess water, solutes, and toxins from the blood in people whose kidneys can no longer perform these functions naturally] or a kidney transplant), and legal blindness, as defined in USA. Mental/Cognitive Status Oriented x 3, Forgetful Caregiver Status: Patient is blind, lives in a residential home and has 24-hour supervision, makes own decisions. Psychosocial Status: Barriers to Heath Status (Multiple co-morbidities, Multiple health providers, Other (Blind) Comments: Patient #8 is legally blind and requires the maximum assistance of another person for safety to prevent falls. Patient #8 nutrition requirements were heart healthy, no concentrated sweets, fluid restriction (1 liter per day), and a renal diet. On 03/01/2024 at 5 PM, HHA 22 returned this writer’s call and indicated they had not received any training on diets and did not know the patient had a fluid restriction. On 03/05/2024 at 10:36 AM, the administrator indicated they don’t have patients on special diets. On 03/05/2024 at 10:55 AM, the clinical manager indicated they had not educated anyone with special diets. 410 IAC 17-14-1(a)(1)(E)”

“Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This Element is not met as evidenced by: Based on record review and interview the skilled nurse failed to ensure verbal orders were obtained for the plan of care from the physician, in 2 of 8 active records reviewed. (Patient #3 and #9) Findings include: 1. Review of an agency document revised April 2019, titled ‘VERIFICATION OF PHYSICIAN ORDERS Policy No. 4-003’ stated, “POLICY To ensure that accurate physician .... orders are obtained in accordance with applicable law and regulation. POLICY Orders will be obtained from a licensed physician ... for care and services to be provided to home health patients. Verbal orders will be spoken to, taken and documented only by professional, licensed home health personnel (RN or therapist) … PROCEDURE An order or prescription will be verified when there is a question or discrepancy in the order/prescription and when the order is communicated by someone other than the physician or his/her agent. The order or prescription reviewed may be the original order, a facsimile copy if permitted by law, or the direct transcription of a verbal order. 2. All telephone orders will be received and processed in accordance with state and federal laws and regulations. 3. All telephone orders or verbal orders will be “read back” to the physician ... or designee to assure accuracy. Orders will be documented on a form provided by A Passionate Helping Hand Home Health Care LLC dated and signed by the professional receiving the order ...” Review of an agency document revised April 2019, titled ‘PHYSICIAN PARTICIPATION IN PLAN OF CARE Policy No. 4-002’ stated, “… POLICY A physician will direct the care of every home health care patient admitted for service. The attending physician will certify that medical, skilled, rehabilitative, and social services provided by the organization are medically necessary and meets the requirements to be covered by Medicare. The attending physician will participate in the care planning process by initiating, reviewing and revising the plan of care … Definition … Verbal order: A physician order that is spoken to appropriate personnel and later put in writing for the purposes of documenting as well as establishing or revising the patient’s plan of care … PROCEDURE … When services are provided on the basis of a physician’s verbal orders, a registered nurse, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law shall document the orders in the patient’s clinical record, and sign, date, and time the orders. 6. … The attending physician’s recertification will be obtained in intervals of at least every 60 days when the patient’s plan of care is reviewed, the patient recertified, and more often, if warranted …” Review of an agency document, revised April 2019, titled ‘REASSESSMENTS/RECERTIFICATION Policy No. 4-020’ stated, “… 10. The physician will be contacted to verify the continued need for care and his/her agreement with the continued plan of care …” 2. Review of the clinical record for Patient #3 failed to evidence documented telephone communication between the agency and physician to obtain verbal orders for the plan of care. The record evidenced a Plan of Care dated 10-16-2023 for the 10-18-2023 through 12-16-2023 certification period which stated, “… SN (Skilled Nurse) received VO (verbal orders) @ 1230 PM for HHC (Home Health Care) Recert for ongoing needs …” signed by the Clinical Supervisor and failed to evidence which physician’s office had been contacted, a date, or contact name for the call. The record also evidenced Plan of Care dated 02-12-2024 for the 2-15-2024 through 04-14-2024 certification period which stated, “… SN received VO @ 1130 AM for HHC Recert for ongoing needs …” signed by Person M and failed to evidence which physician’s office had been contacted, a date, or contact name for the call. The record also evidenced a document dated 12-13-2023 titled ‘Physician’s Order’ indicated, “VO RECEIVED TO RECERT FOR ONGOING HHC NEEDS” signed by Person M, with box check marked that stated, “ORDER READ BACK AND VERIFIED” and failed to evidence whether the verbal or was given by the physician or the physician’s representative. Additionally, the record evidenced a document dated 02-12-2024 titled ‘Physician’s Order’ which indicated, “VO RECEIVED TO RECERT FOR ONGOING HHC NEEDS” signed by the Clinical Supervisor, with box check marked that stated, “ORDER READ BACK AND VERIFIED” and failed to evidence whether the verbal or was given by the physician or the physician’s representative. Review of the clinical record for Patient #9 failed to evidence documented telephone communication between the agency and physician to obtain verbal orders for the plan of care. The record evidenced an updated resumption Plan of Care dated 02-26-2024 for the 02-10-2024 through 04-09-2024 certification period which stated, “… SN (Skilled Nurse) received VO (verbal orders) for resumption for care for ongoing services … drug interactions reported to Doctor HH, no new orders …” was signed by RN 1 and failed to evidence which physician’s office had been contacted, a date, a time, or contact name for the call. The record evidenced a document dated 02-26-2024 titled ‘Physician’s Order’ which indicated, “VO RESUMPTION OF CARE FOR CONTINUING HHC NEEDS & SERVICES” signed by the RN 1, with box check marked that stated, “ORDER READ BACK AND VERIFIED” and failed to evidence whether the verbal or was given by the physician or the physician’s representative. 3. On 02-28-2024 at 11:34 AM, in a telephone interview regarding Patient #3 with Person JJ, of Doctor I’s office, indicated had not received any telephone communication from A Passionate Helping Hand since March of 2023, specifically no requests for verbal orders. On 02-28-2024 at 4:00 PM, when queried as to whom she usually speaks to at Doctor I’s office and when the last call may have been, the Clinical Supervisor indicated could not remember. On 02-29-2024 at 12:50 PM, the Clinical Supervisor indicated had not been documenting who they speak to at physicians’ offices when obtaining verbal orders. On 03-04-2024 at 11:45 AM in a telephone interview regarding Patient #9, with Person II of Doctor HH’s office, when queried as to whether the agency calls for verbal orders, indicated “I used to hear from [office manager] all the time”, but not recently, and indicated did not receive calls from the agency requesting verbal orders. Indicated the doctor’s office often receives faxes instead. On 03-05-2024 at 10:30 AM, the Administrator indicated the office manager (non-clinical) used to obtain verbal orders for the agency. 410 IAC 17-14-1 (a)(1)(G)”

“A qualified HH aide successfully completed: CFR(s): 484.80(a)(1)(i-iv) A qualified home health aide is a person who has successfully completed: (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure the agency hired qualified home health aides and failed to ensure they were competent to carry out assigned patient care tasks in 16 of 18 HHA personnel files reviewed. (HHA 2, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20). Findings include: 1. A review of an agency document, revised April 2019 titled, ‘CATEGORIES/QUALIFICATIONS OF PERSONNEL’ Policy No. 1-005.1-4 revealed, “PURPOSE to define personnel/staffing categories and classifications. POLICY … 3. The organization will employ or contract only those individuals who have valid credentials as stipulated by state and federal requirements. 4. Personnel qualifications include appropriate … certification for those positions designated by law and regulation … QUALIFICATIONS OF ORGANIZATION PERSONNEL … Para-Professional and Support Personnel: 1. Home Health Aide … Competency … Individuals must demonstrate their competency, within orientation, according to the orientation checklist and the activities delineated in the CMS … competency testing … “ A review of an agency document, revised April 2019 titled, ‘SELECTION/HIRING OF PERSONNEL’ Policy No. 1-0061-2 revealed, “PURPOSE To specify the criteria for the recruitment and hiring of employees to meet the care/service needs of patients. POLICY … The most qualified individuals will be employed … PROCEDURE … B. At least one (1) year of experience and/or as defined in the job description … 4. Two (2) references, either telephone and/or written, will be obtained prior to an offer of employment … 6. … certification will be confirmed … “ 2. The review of HHA 2 personnel file revealed job responsibilities included cleaning, maintenance, assisted with appointments, and errands, the Home Health Aide/Hospice Aide Competency Checklist failed to identify dates and initials of the RN of each competency Assessment skill, the qualified RN Evaluator Signature/Title and dated 07/29/2023 was Administrative Staff 3 a registered nurse, signed by HHA 2 on 07/29/2023. The review of HHA 2 personnel file failed to evidence HHA 2 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 3. The review of HHA 5 personnel file with their application signed on 09/06/2023, job responsibilities included stocking shelves, a Home Health-Hospice Aide Competency Assessment Exam Answer sheet was signed by HHA 5 but failed to evidence a date or that it had been graded, on 09/19/2023, the Initial Home Health Aide/Hospice Aide Competency Checklist failed to identify dates and initials of RN of each competency Assessment skill and failed to have HHA 5 and the qualified RN Evaluator Signatures/Title and dated. The review of HHA 5 personnel filed failed to evidence HHA 5 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 4. The review of HHA 7 personnel file revealed an application for HHA dated 11/16/2023, job responsibilities included transporting medical supplies, the Home Health -Hospice Aide Competency assessment Exam failed to evidence a date and not graded, the Home Health Aide/Hospice Aide Competency Checklist dated 11/13/2023 failed to identify dates and initials of RN of each competency Assessment skills, the qualified RN Evaluator Signature/Title and dated 11/13/2023 was Administrative Staff 2, and signed by HHA 7 on 11/13/2023. The review of HHA 7 personnel file failed to evidence HHA 7 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 5. The review of HHA 8 personnel file evidenced an application dated 11/27/23 the position applied for was HHA which failed to evidence work history and references, the Home health-Hospice Aide Competency Assessment Exam failed to evidence it was graded, dated 11/27/2023, the Home Health Aide/Hospice Aide Competency Checklist dated 12/04/2023 failed to identify dates and initials of RN in each of the competency Assessment skills, the qualified RN Evaluator Signature/Title and dated 12/04/2023 was signed by Administrative Staff 2 and signed by HHA 8 on 12/4/2023. p The review of HHA 8 personnel file failed to evidence HHA 8 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 6. The review of HHA 9 personnel file evidenced an application dated 09/12/2023, work history included overnight stock, and a pick and packer, the Home Health-Hospice Aide Competency Assessment exam failed to evidence a grade, dated 10/03/2023, the Home Health Aide/Hospice Aide Competency Checklist, failed to identify dates and initials of RN of each competency Assessment skills, the qualified RN Evaluator Signature/Title was Administrative Staff 2 signed 10/05/2023 and signed by HHA 9 on 10/05/2023. The review of HHA 9 personnel file failed to evidence HHA 9 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 7. The review of HHA 10 personnel file evidenced an application dated 08/18/2023, the position applied for was HHA, work history was logistics, pallet repairs, a warehouse associate, the Home Health-Hospice Aide Competency Assessment exam failed to evidence a grade, dated 10/07/2023, the Home Health Aide/Hospice Aide Competency Checklist indicated it was completed on 08/18/2023 but it failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was Administrative Staff 3 signed ion 08/18/2023 and signed by HHA 9 on 08/18/2023. The review of HHA 10 personnel file failed to evidence HHA 10 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 8. The review of HHA 11 personnel file evidenced an application dated 09/29/2023, work history was residential home, the Home Health-Hospice Aide Competency Assessment exam failed to evidence a date or grade, dated 10/07/2023, and failed to evidence a Home Health Aide/Hospice Aide Competency Checklist. The review of HHA 11 personnel file failed to evidence HHA 11 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 9. The review of HHA 12 personnel file evidenced an application dated 10/16/2023, the position applied for was HHA, the work history was operating a forklift, the Home Health-Hospice Aide Competency Assessment exam failed to evidence a grade, dated 10/18/2023. The review of HHA 12 personnel file failed to evidence HHA 12 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 10. The review of HHA 13 personnel file evidenced an application dated 05/29/2023, the application failed to identify the position applied, the work history was customer service, the Home Health-Hospice Aide Competency Assessment exam evidenced a passing grade, undated and signed by the Clinical Manager, the Competency Assessment skills indicated it was completed on 05/30/2023 but it failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title signed by the Clinical Manager on 05/30/2023 and signed by HHA 9 on 05/30/2023. The review of HHA 13 personnel file failed to evidence HHA 13 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 11. The review of HHA 14 personnel file evidenced an application dated 10/23/2023, the position applied for was home health care aide, the work history was front desk check-in, the Home Health-Hospice Aide Competency Assessment exam, failed to evidence a grade, dated 10/30/2023, the Competency Assessment skills failed to indicate when it was completed, failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was the Clinical Manager but failed to date it, HHA 14 signed on 10/31/23. The review of HHA 14 personnel file failed to evidence HHA 14 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 12. The review of HHA 15 personnel file evidenced an application dated 10/06/2023, the position applied for was caregiver, the work history was transportation and caregiver, the Competency Assessment skills indicated it was completed on 12/04/2024 but failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was the Clinical Manager dated 12/04/2023, HHA 15 signed on 12/04/2023. The review of HHA 15 personnel file failed to evidence HHA 15 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 13. The review of HHA 16 personnel file evidenced an application dated 08/14/2023, the position applied for was caregiver, the work history was returns of merchandise, the Home Health-Hospice Aide Competency Assessment exam failed to evidence a grade, the Competency Assessment skills indicated it was completed on 08/14/2023 but failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was the Clinical Manager dated 08/14/2023, HHA 16 signed on 08/14/2023. The review of HHA 16 personnel file failed to evidence HHA 16 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 14. The review of HHA 17 personnel file evidenced an application dated 10/03/2023, the position applied for was caregiver, the work history was retail sale associate and packing, the Competency Assessment skills indicated it was completed on 12/04/2023 but failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was the Clinical Manager dated 12/04/2023, HHA 17 signed on 12/04/2023. The review of HHA 17 personnel file failed to evidence HHA 17 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 15. The review of HHA 18 personnel file evidenced an application dated 11/01/2023, the position applied for was home health aide, the work history was box and send out packages, the Home Health-Hospice Aide Competency Assessment exam dated 11/06/2023, failed to evidence a grade, the Competency Assessment skills indicated it was completed on 12/01/2023 but failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was the Clinical Manager dated 12/01/2023, HHA 18 signed on 12/01/2023. The review of HHA 18 personnel file failed to evidence HHA 18 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 16. The review of HHA 19 personnel file evidenced an application dated 11/21/2023, the position applied for was caregiver, the work history was a preschool teacher and caregiver, the Home Health-Hospice Aide Competency Assessment exam failed to evidence a name or date, and failed to evidence a grade, the Competency Assessment skills indicated it was completed on 11/27/2023 but failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was the Clinical Manager dated 11/27/2023, HHA 19 signed on 11/27/2023. The review of the personnel file for HHA 19 failed to evidence HHA 19 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 17. The review of the personnel file for HHA 20 evidenced an application dated 08/10/2023, the position applied for was caregiver, the work history was customer service, the Home Health-Hospice Aide Competency Assessment exam failed to evidence a name or date, and failed to evidence a grade, the Competency Assessment skills indicated it was completed on 08/102023 but failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was the Clinical Manager dated 08/10/2023, HHA 20 signed on 08/10/2023. The review of the personnel file for HHA 20 failed to evidence HHA 20 had previous home health aide experience and failed to ensure they were competent to carry out patient assignments. 18. On 02/28/2024 at 9:29 AM during an interview, with Administrative Staff 5, the Human Resources Manager indicated the agency hires anyone that passes the criminal history checks, the clinical manager conducts the training of everyone the agency hires, including HHA skill check-offs, that it usually takes 2 hours when training a group of people, once the skills are checked off, it’s sent to state but we don’t use them until the HHA certificate is received, that they check the state web site daily after being submitted and print off the certificate from the state site, and let HHA 4, the scheduler know they’re ready to staff. On 02/28/2024 at 10:31 AM during an interview with the clinical director indicating they hire just about everyone that walks through the door, and as long as they pass the criminal background, they give each person the home health aide written test to complete, once the test is completed, they submit the written test to the state and once the certificate is received before they are staffed with a patient, they go over the skills check-offs and let HHA 4, the scheduler know so they can be staffed. When queried how the clinical manager was taught to do the HHA training, they indicated the administrator and Person B, the former clinical manager instructed them to do the training that way and indicated that they had been training employees since April of 2023. On 02/29/2024 at 1:06 PM, the administrator indicated they put everyone through training (at their school, explaining they had a program to teach people to become certified HHA’s) before applying for a position at the agency. This writer showed her the documentation of the testing from the personnel file review and the administrator indicated it didn’t look like 75 hours of training had been completed, indicated that if it’s not signed and dated, it didn’t happen, then indicated they hadn’t conducted HHA training classes for some time. On 03/01/2024 at 2:47 PM, when queried the administrator how long it had been since they had conducted HHA training classes, the administrator indicated it had been since February/March of 2023. 410 IAC 17-14-1(i)(1)(A)”

“Classroom and supervised practical training CFR(s): 484.80(b)(1) Home health aide training must include classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. Classroom and supervised practical training must total at least 75 hours. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the classroom and supervised practical training totaled at least 75 hours under the direct supervision of a registered nurse (RN) of 16 home health aides personnel records of 18 reviewed. (HHA 2, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20. Findings include: 1. A review of an agency document, revised April 2019 titled, ‘HOME HEALTH AIDE TRAINING’ Policy No. 1-029.1-6 revealed, “PURPOSE To outline a home health aide training program to ensure the competence and skills of home care aides. POLICY (Agency) will only hire individuals as home health aides … who have completed a training program … Criteria 1. A home health aide training program must include a minimum of 75 hours … at least 16 hours of supervised practical training and 16 hours of classroom instruction, completed prior to the supervised practical training … 4. Instructors for home health aide training … must be registered nurses … “ 2. The review of HHA 2 personnel file evidenced the Certified Home Health Aide job description was signed and dated by HHA 2 on 06/16/2023, a Home Health-Hospice Aide Competency Assessment Exam Answer sheet was signed and dated by HHA 2 on 06/16/2023, the Home Health Aide/Hospice Aide Competency Checklist failed to identify dates and initials of (RN)Registered Nurse of each competency Assessment skills, the qualified RN Evaluator Signature/Title and dated 07/29/2023 was Administrative Staff 3, signed by HHA 2 on 07/29/2023. HHA 2 received their HHA certification on 08/03/2025. 3. The review of HHA 5 personnel file evidenced the Certified Home Health Aide job description was signed and dated by HHA 5 on 09/19/2023, a Home Health-Hospice Aide Competency Assessment Exam Answer sheet was signed by HHA 5 but failed to evidence a date or that it had been graded, the Initial Home Health Aide/Hospice Aide Competency Checklist failed to identify dates and initials of the RN of each competency Assessment skills and failed to have HHA 5 and the qualified RN Evaluator Signatures/Title and dated. HHA 5 received their HHA certification on 11/01/213. 4. The review of HHA 6 personnel file evidenced documents titled, ‘JOINT VISIT ASSESSMENT’ and INITIAL COMPETENCY ASSESSMENT SKILLS CHECKLIST HOME HEALTH AIDE’ completed on 07/18/2023 and signed by Person N, a former office assistant. HHA 6 received their HHA certificate on 07/20/2023. 5. The review of HHA 7 personnel file evidenced a HHA job description signed on 11/16/2023, the Home Health -Hospice Aide Competency assessment Exam failed to evidence a date and not graded, the Home Health Aide/Hospice Aide Competency Checklist dated 11/13/2023, failed to identify dates and initial of RN of each competency Assessment skills, the qualified RN Evaluator Signature/Title and dated 11/13/2023 was Administrative Staff 2, and signed by HHA 7 on 11/13/2023. HHA 7 received their HHA certification on 11/28/2023. 6. The review of HHA 8 personnel file evidenced the Home Health Aide job description was signed and dated by HHA 8 on 11/27/2023, the Home health-Hospice Aide Competency Assessment Exam failed to evidence it was graded, dated 11/27/2023,d the Home Health Aide/Hospice Aide Competency Checklist dated 12/04/2023 failed to identify dates and initials of the RN in each of the competency Assessment skills, the qualified RN Evaluator Signature/Title and dated 12/04/2023 was signed by Administrative Staff 2 and signed by HHA 8 on 12/4/2023. HHA 8 received their HHA Certification on 12/7/2023. 7. The review of HHA 9 personnel file evidenced a job description signed on 10/03/2023, the Home Health-Hospice Aide Competency Assessment exam failed to evidence it was graded, dated 10/03/2023, the Home Health Aide/Hospice Aide Competency Checklist, failed to identify dates and initials of the RN of each competency Assessment skills, the qualified RN Evaluator Signature/Title was Administrative Staff 2 signed 10/05/2023 and signed by HHA 9 on 10/05/2023. HHA 9 received their HHA certification on 10/31/2023. 8. The review of HHA 10 personnel file evidenced the HHA job description was signed on 08/08/2023, the Home Health-Hospice Aide Competency Assessment exam failed to evidence a grade, dated 10/07/2023, the Home Health Aide/Hospice Aide Competency Checklist failed to be completed on 08/18/2023 but the qualified RN Evaluator Signature/Title was Administrative Staff 3 signed on 08/18/2023 and signed by HHA 10 on 08/18/2023. HHA 10 received their HHA certification on 10/31/2023. 9. The review of HHA 11 personnel file evidenced the HHA job description was signed by HHA 11 on 10/12/2023, the Home Health-Hospice Aide Competency Assessment exam failed to evidence a date or grade, dated 10/07/2023, and failed to evidence a Home Health Aide/Hospice Aide Competency Checklist, HHA 11 received their HHA certification on 10/31/2023. 10. The review of HHA 12 personnel file evidenced the HHA job description was signed by HHA 10 on 10/31/2023, and the Home Health-Hospice Aide Competency Assessment exam failed to evidence it was graded, dated 10/18/2023, the Competency Assessment skills was completed on 12/21/2023, the qualified RN Evaluator Signature/Title was RN 1 signed 12/21/2023 and signed by HHA 9 on 12/21/2023. HHA 10 received their HHA certification on 12/28/2023. 11. The review of HHA 13 personnel file evidenced the HHA job description was signed by HHA 13 on 05/29/2023, and the Home Health-Hospice Aide Competency Assessment exam evidenced a passing grade, undated and signed by the Clinical Manager, the Competency Assessment skills indicated it was completed on 05/30/2023 but it failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title signed by the Clinical Manager on 05/30/2023 and signed by HHA 9 on 05/30/2023. HHA 13 personnel file evidenced a HHA certification issued on 09/26/2023. 12 The review of HHA 14 personnel file evidenced the HHA job description was signed by HHA 14 which failed to evidence a date, and the Home Health-Hospice Aide Competency Assessment exam, ungraded, dated 10/30/2023, the Competency Assessment skills failed to indicate when it was completed, failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was the Clinical Manager but failed to date it, HHA 14 signed on 10/31/23. HHA 14 personnel file evidenced a HHA certification issued on 12/07/23. 13. The review of HHA 15 personnel file evidenced the HHA job description was signed by HHA 15 on 10/31/2023, the Home Health-Hospice Aide Competency Assessment exam, dated 10/06/2023, the Competency Assessment skills indicated it was completed on 12/04/2024 but failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was the Clinical Manager dated 12/04/2023, HHA 15 signed on 12/04/2023. HHA 15 personnel file evidenced an HHA certification issued on 01/25/2024. 14. The review of HHA 16 personnel file evidenced the HHA job description was signed by HHA 16 on 08/14/2023, the Home Health-Hospice Aide Competency Assessment exam failed to be graded, the Competency Assessment skills indicated it was completed on 08/14/2023 but failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was the Clinical Manager dated 08/14/2023, HHA 16 signed on 08/14/2023. HHA 16 personnel file evidenced an HHA certification issued on 08/15/2023. 15. The review of HHA 17 personnel file evidenced the HHA job description was signed by HHA 17 on 11/28/2023, the Home Health-Hospice Aide Competency Assessment exam dated 12/06/2023, the Competency Assessment skills indicated it was completed on 12/04/2023 but failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was the Clinical Manager dated 12/04/2023, HHA 17 signed on 12/04/2023. HHA 17 personnel file evidenced an HHA certification issued on 12/07/2023. 16. The review of HHA 18 personnel file evidenced the HHA job description was signed by HHA 18 on 11/29/2023, the Home Health-Hospice Aide Competency Assessment exam dated 11/06/2023, ungraded, the Competency Assessment skills indicated it was completed on 12/01/2023 but failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was the Clinical Manager dated 12/01/2023, HHA 18 signed on 12/01/2023. HHA 18 personnel file evidenced an HHA certification issued on 12/07/2023. 17. The review of HHA 19 personnel file evidenced the HHA job description was signed by HHA 19 on 11/21/2023, the Home Health-Hospice Aide Competency Assessment exam failed to evidence a name or date and was ungraded, the Competency Assessment skills indicated it was completed on 11/27/2023 but failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was the Clinical Manager dated 11/27/2023, HHA 19 signed on 11/27/2023. HHA 19 personnel file evidenced an HHA certification issued on 12/07/2023. 18. The review of HHA 20 personnel file evidenced the HHA job description was signed by HHA 20 on 08/10/2023, the Home Health-Hospice Aide Competency Assessment exam failed to evidence a name or date and was ungraded, the Competency Assessment skills indicated it was completed on 08/102023 but failed to identify dates and initials of the RN for each of the competency Assessment skills, the qualified RN Evaluator Signature/Title was the Clinical Manager dated 08/10/2023, HHA 20 signed on 08/10/2023. HHA 20 personnel file evidenced an HHA certification issued on 09/14/2023. 19. On 02/28/2024 at 9:29 AM during an interview, with Administrative Staff 5, the Human Resources Manager indicated the agency hires anyone who passes the criminal history checks, the clinical manager conducts the training of everyone the agency hires, including HHA skill check-offs, that it usually takes 2 hours when training a group of people, once the skills are checked off, it’s sent to state but we don’t use them until the HHA certificate is received, that they check the state web site daily after being submitted and print off the state site, and inform HHA 4, the scheduler they’re ready to be staff. On 02/28/2024 at 10:31 AM during an interview with the clinical director indicating they give each person the written test to complete, once the test is completed, they submit the written test to the state and once the certificate is received before they are staffed with a patient, they go over the skills check-offs and then inform HHA 4, the scheduler know so they can be staffed. When queried how the clinical manager was taught to do the HHA training, they indicated the administrator and Person B, the former clinical manager instructed them to do the training that way and indicated that they had been training employees since April of 2023. On 02/29/2024 at 1:06 PM, the administrator indicated they put everyone through training (at their school, explaining they had a train the Trainer program to teach people to become certified HHA’s) before applying for a position at the agency. This writer showed her the documentation of the testing from the personnel file review and the administrator indicated it didn’t look like 75 hours of training had been completed, indicated that if it’s not signed and dated, it didn’t happen, then indicated they hadn’t conducted HHA training classes for some time. On 03/01/2024 at 2:47 PM, when queried the administrator how long it had been since they had conducted HHA training classes, the administrator indicated it had been since February/March of 2023.”

“Duties of a HH aide CFR(s): 484.80(g)(3) The duties of a home health aide include: (i) The provision of hands-on personal care; (ii) The performance of simple procedures as an extension of therapy or nursing services; (iii) Assistance in ambulation or exercises; and (iv) Assistance in administering medications ordinarily self-administered. This Element is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the HHA performed HHA duties for each patient as ordered in 2 of 2 home visits conducted. (Patient #3 and 4) Findings include: 1. A review of the clinical record for Patient #4 revealed a Home Health Certification and Plan of Care document for the certification period of 01/25/2024 – 03/24/2024 which evidenced diagnoses but not limited to Cerebral Palsy (a group of disorders that affect a person’s ability to move and maintain balance and posture. Cerebral means having to do with the brain and palsy means weakness or problems with using the muscle[s]), indicated patient #4 was alert and oriented. Patient #4 was to receive HHA (home health services) 5 times a week for 9 weeks up to 8 hours a day. A review of Patient #4 record evidenced HHA 1 visits, documented their HHA visits as follows but not limited to: clocking in: 7:30 AM - 11 PM to clocking out at 5:30 PM – 9:30 PM Monday through Friday. On 02/23/2024 at 9:31 AM, upon knocking on Patient’s #4 door, with Patient #4 not answering their door, this writer walked back into the common area and looked down the other hall to find Patient #4 in the doorway to an apartment where HHA 1 was cooking. When this writer approached Patient #4 and introduced themselves, Patient #4 indicated that HHA 1 was cooking breakfast for everyone. This writer asked if we could go to their apartment and talk, Patient #4 indicated that was fine, and proceeded to their apartment while HHA 1 continued to stay in that apartment and cook. Patient #4’s apartment contained a kitchenette with a stove and refrigerator, and when queried Patient #4 why HHA 1 was cooking breakfast in the other apartment, they indicated some of the occupants share meals at Entity E, usually in the common area. This writer continued to review the agency binder and thanked Patient #4 for taking the time. HHA1 never entered Patient #4’s apartment while this writer was there. 2. A review of the clinical record for Patient #3 evidenced HHA #2 was regularly assigned to Patient #3 to complete care during the daytime, as evidenced by six months of HHA visit notes completed and signed by HHA#2. HHA #1 was not scheduled to provide care for Patient #3 for the agency. 3. On 02/23/2024 at 9:56 AM, HHA 1 indicated they go back and forth between Patient #3 and Patient #4 helping them both with whatever needs to be done for each one throughout the day, and quite often to cook for several people in the building. On 02/27/2024 at 3:46 PM, the clinical manager indicated they weren’t sure what was going on in that building (the apartment building where Patient #3 and #4 reside), not sure who was taking care of who and when, and would have a conversation with the aides. On 02/26/2024 at 2:26 PM, the administrator indicated that if a home health aide is cooking for one they should cook for all. 410 IAC 17-14-1)h)(1)-(14)”

“Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This Element is not met as evidenced by: Based on record review and interview the Administrator failed to maintain responsibility and oversight for all day-to-day operations and instead relinquished responsibilities and duties to other unqualified individuals on an ongoing basis. Findings include: 1. Review of an agency document revised April 2019, titled ‘APPOINTMENT OF EXECUTIVE DIRECTOR/ADMINISTRATOR Policy No. 1-007’ stated, “POLICY … The Executive Director/Administrator will: Be responsible for the day-to-day operations of the organization. 2. Have the necessary authority to implement his/her responsibilities for the operations, as conferred by the Governing Body. 3. Have at least two (2) years health related experience and the education, knowledge, and ability to fulfill his/her responsibilities. A master’s degree is preferred. 4. Be knowledgeable of applicable law and regulation including Medicare Conditions of Participation as applicable, state regulations, licensure requirements, and any other applicable local/state/or federal regulations. 5. Take reasonable steps to assure that: A. The organization complies with applicable laws and regulations …” 2. Review of the personnel file for the Administrator failed to evidence a job description for the role of Administrator, but evidenced an untitled document which appeared to be only the signature page “3 of 6”, (no additional pages for the document were present), listed the regulatory requirements for an administrator, and was signed by the Administrator on 10-19-2020. The personnel file contained an LPN (Licensed Practical Nurse) orientation, but failed to evidence orientation to the role of Administrator. Review of an Indiana Department of Health document dated 12-22-2023, titled ‘FAX’ evidenced a fax cover sheet containing the name of the agency’s office manager as the sender. ‘Notes:’ stated, “… I, [Alternate Clinical Supervisor’s name] have attached a letter to remove my name from a home care agency …” The attached letter stated, “… To whom this may concern: I would like to remove my name as the Alternate Administrator and Alternate Clinical Manager of A Passionate Helping Hand Home Health Care effective immediately. I have been made aware of some unethical behavior and concerns and would not want my name or license placed in jeopardy if this is found to be true and substantiated. Thank you, [Alternate Clinical Supervisor’s name] …” and the document was signed. 3. On 02-22-2024 at 9:35 AM, the Administrator indicated did not have access to the Gateway (a portal for electronic communications with the Indiana Department of Health) and indicated the office manager would be the only one who submits information through the Gateway. Indicated the office manager informed her when associated emails came in. On 02-22-2024 at 10:03 AM, when queried as to who the members of the Governing Body were, the Administrator indicated the members included herself and the office manager, was unsure of the other members, and indicated the office manager could provide a list of members. On 02-22-2024 at 10:12 AM, when queried regarding the agency’s QA process and who reviews clinical documentation, the Administrator indicated that the office manager (who is not clinical) was the only person doing this, “QA’s nurses’ visits and home health aides and therapy”. On 02-23-2024 at 12:47 PM, the Administrator and Clinical Supervisor were queried as to who scheduled aides, and the office manager answered for them and indicated the scheduler performed this task, when queried as to how the scheduler would know what hours to schedule, the office manager indicated there was spreadsheet which contained approved hours which the scheduler utilized to set the schedules. The office manager then indicated the scheduler “QA’s the schedules” and adjusts the time, for example when adjustments are needed when an aide might clock-out late. When queried as to who the members of the Governing Body were, the office manager answered for the group, and indicated the members included herself, the Administrator, the Clinical Supervisor, and one individual from each discipline of the agency. On 02-23-2024 at 2:21 PM, the Administrator and office manager were queried regarding a letter sent to the Indiana Department of Health (IDOH) on 12-22-2023 which indicated the Alternate Clinical Supervisor wished to provide notice to the department that they were no longer affiliated with the agency. The letter requested to have their name removed as the Alternate Administrator and Alternate Clinical Supervisor “effective immediately”, owing to “some unethical behavior and concerns” and not wanting to be affiliated with such an agency. The signature on the letter did not match other signed documents found in the personnel file for the Alternate Clinical Supervisor. The fax number on the cover sheet did not belong to the agency and the name appearing on the fax cover sheet evidenced the name of the office manager. When asked to explain the cover sheet, the office manager admitted it was a fax number from a different home health agency, Entity GG (which she currently owned), and stated, “I have no idea”. The administrator then inspected the fax cover sheet and confirmed the fax number was not an agency number. When the Administrator was shown the letter sent to IDOH, indicated had not seen this before, had not sent this letter to IDOH, and was not aware that the Alternate Clinical Supervisor had resigned from their position. On 02-23-2024 at 2:30 PM the Administrator indicated the office manager (who is non-clinical) “is teaching me, I don’t know, I am still learning the COPs (Conditions of Participation).” On 02-26-2024 at 10:07 AM, when queried about specific hours patients have aide visits, the Administrator indicated was not certain, “They put their own hours in”, indicating the aides scheduled themselves. On 02-26-2024 at 2:12 PM, when queried as to who did the scheduling, the Administrator indicated Person N did the scheduling, but the aides scheduled themselves and indicated the office manager scheduled a majority of the nurses. When queried regarding who was responsible for the billing, the Administrator indicated she had no part of the agency’s billing and the office manager was the one who handled this, “100%”. The office manager also handled authorizations for “PA’s, 100%”, and payroll was handled by an outside accountant. On 02-26-2024 at 3:09 PM, when queried as to whether they were familiar with the Federal Regulations for the Administrator and the Clinical Supervisor, the Administrator indicated, “not fully, still learning” and the Clinical Supervisor indicated was still learning as well. On 02-26-2024 at 3:47 PM, the office manager confirmed she indeed performed the QA function and indicated if something didn’t look right would check with the Clinical Supervisor. Indicated was able to send ‘sticky notes’ back to clinicians to inform of needed corrections. On 02-26-2024 at 3:51 PM, when queried, the Administrator was not aware that current billing records continued to display the agency’s old address. On 02-29-2024 at 1:08 PM when queried as to how Home Health Training was provided and by whom, the Administrator, was presented with evidence of Person N signing off on Home Health Aide training documents, the Administrator indicated, “she shouldn’t be signing that”. The Administrator was shown additional Home Health Aide training documentation which Person N signed off on, the Administrator then indicated Person N was, “not even a nurse”. On 02-29-2024 at 12:57 PM, when queried as to overlapping Home Health aide hours and PSA aide hours for Patients #3 and #4, the Administrator indicated this would appear to be “stealing time”, “not giving patient all their time”, and “it’s illegal”. And indicated for the PSA side, “We set those hours”. When queried as to who had oversight over scheduling, did not answer. When queried if the scheduler, Person N, was who oversaw scheduling, the Administrator did not answer. On 03/01/2024 at 10:48 AM, the Administrator indicated they should know all the answers to Emergency Preparedness but was still learning and wished to have all questions deferred to the office manager. This writer asked the Administrator if they understood that the Administrator is responsible for emergency preparedness, and they indicated they understood. On 03-01-2024 at 2:50 PM, the Administrator indicated did not know Home Health aides could not provide transport and could not go to appointments with patients. On 03-05-2024 at 1:05 PM, when queried as to how supervisory visits are performed and how often the Clinical Manager indicated “every 14 - 30 days” and the Administrator indicated “every episode”. The Clinical Supervisor when asked if visits are done in person, indicated if it’s a patient she sees, she may call them but has done in-person supervisory visits and via phone. The Administrator indicated another nurse had been doing this, and indicated “some nurses do”, then replied, “so, I guess we shouldn’t be doing that”. On 03-05-2024 at 10:30 AM, the Administrator indicated the office manager used to obtain verbal orders. On 03-05-2024 at 1:16 PM, the Administrator indicated that if the agency recognized a patient requires 24-hour care, “maybe they need a skilled facility”. On 03-05-2024 at 4:32 PM, the Administrator indicated was not aware the website for the agency still contained the agency’s old address had not been updated. 410 IAC 17-12-1(b)(3) 410 IAC 17-12-1((c)(1)”

“Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure the agency had an Alternate Administrator. Findings include: 1. Review of an agency document revised April 2019, titled ‘DESIGNATION OF INDIVIDUAL IN ABSENCE OF EXECUTIVE DIRECTOR/ADMINISTRATOR Policy No. 1-00B’ stated, “PURPOSE To facilitate smooth and uninterrupted daily operations of A Passionate Helping Hand Home Health Care LLC during time off of administrative personnel, POLICY A Passionate Helping Hand Home Health Care LLC will have an Executive Director/Administrator or designee available at all times. PROCEDURE ... In the event that the Executive Director/Administrator is absent, the Clinical Director will assume the operational duties and responsibilities at A Passionate Helping Hand Home Health Care LLC ... 2. in the event both are absent, an appropriately qualified nurse will assume the responsibilities. 3. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence.” 2. On 02-22-2024 at 9:43 AM during the entrance conference, the Administrator indicated the agency currently did not have anyone serving in the role of Alternate Administrator. On 02-22-2024 at 1:26 PM in a telephone interview with the Alternate Clinical Supervisor, when queried if they held any other title, indicated they had no other title/position at the agency and indicated had not had a break in their employment. 410 IAC 17-12-1(d)(8)”

“Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure the Clinical Supervisor was responsible for making personnel and patient assignments. Findings include: 1. Review of an agency document titled ‘Job Title/Position: Clinical Supervisor’ stated, “… The Clinical Supervisor is responsible for ensuring that patient care is coordinated and managed appropriately. The Clinical Supervisor is responsible for ensuring that care and services are delivered appropriately as well as the supervision of clinical personnel … ESSENTIAL JOB FUNCTIONS/RESPONSIBILITIES … Assigns appropriate clinicians to case …” 2. On 02-23-2024 at 12:47 PM, the Administrator and Clinical Supervisor were queried as to who scheduled aides, and the office manager answered for them and indicated the scheduler performed this task, when queried as to how the scheduler would know what hours to schedule, the office manager indicated there was spreadsheet which contained approved hours which the scheduler utilized to set the schedules. The office manager then indicated the scheduler “QA’s the schedules” and adjusts the time, for example when adjustments are needed when an aide clocked-out late. On 02-26-2024 at 2:12 PM, when queried as to who did the scheduling, the Administrator indicated Person N did the scheduling, but the aides scheduled themselves and indicated the office manager scheduled a majority of the nurses. On 02-26-2024 at 3:09 PM, when queried as to whether they were familiar with the Federal Regulations for the Administrator and the Clinical Supervisor, the Administrator indicated, not fully, still learning and the Clinical Supervisor indicated was still learning as well. 410 IAC 17-14-1(a)(1)(K)”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure the agency failed to ensure a faxed physician’s order had been integrated into the Electronic Medical Record (EMR) for over six (6) months, in 1 of 8 active records, of 10 active and closed clinical records reviewed. (Patient #3) Findings include: 1. Review of an agency document, revised April 2019, titled “VERIFICATION OF PHYSICIAN ORDERS Policy No. 4-003’ stated, “POLICY Orders will be obtained from a licensed physician (or other authorized licensed independent practitioner) for care and services to be provided to home health patients … A qualified individual will review each order or prescription before care is provided … 5. A copy of the physician’s … order will be kept in the clinical record …” 2. Review of the paper clinical record for Patient #3 evidenced an order from Doctor I’s office dated 09-20-2023 which stated, “… Referrals; Home Health Evaluate and treat … Clinical Indications/Reason for Referral: insulin administration/medication management …” 3. On 02-29-2024 at 9:37 AM, in an interview with the office manager, regarding a written order for Patient #3 found in the paper chart, she indicated anything uploaded to the electronic record would be found in “Documents”, she was also unable to locate this order in the electronic medical record (EMR) system and the only copy was housed in the patient binder. The office manager indicated the last upload to the chart appeared to be 08-30-2023. On 02-29-2024 at 9:50 AM, in an interview with the Clinical Supervisor, indicated had not ever seen the paper document with the physician’s order from 09-20-2023 for nursing to provide insulin administration and medication management and was surprised to learn the agency had this document in their possession since September of 2023. 410 IAC 17-15-1(a)(1)-(7)”

“Contact information for the patient CFR(s): 484.110(a)(4) Contact information for the patient, the patient’s representative (if any), and the patient’s primary caregiver(s); This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure the contact information was accurate for the patient on the plan of care in 1 of 8 active records reviewed. (Patients #4) Findings include: 1. A review of an agency’s policy dated revised April 2019 titled, ‘CONTENTS OF CLINICAL RECORD’ Policy No. 4-047.1-.3 revealed, “PURPOSE To outline the requirements and components of a clinical record … PROCEDURE 1. … A. Patient’s … phone number … “ 2. A review of the clinical record for Patient #4 revealed a Home Health Certification and Plan of Care document for the certification period of 01/25/2024 – 03/24/2024 with a start of care date of 05/30/2023, evidenced the contact phone number for Patient #4 was the same as HHA 1. On 02/23/2024 at 9:31 AM Patient #4 indicated HHA 1 said it would be easier for everyone if their HHA 1 phone number was used as a contact number. 3. On 02/23/2024 at 9:54 AM, HHA 1 indicated they gave the nurse who did the initial assessment their number, so they could be there if needed since Patient #4 doesn’t have family close by. On 02/27/2024 at 1:40 PM, the clinical manager indicated they knew the phone number on the plan of care for Patient #4 was HHA 1’s cell phone, but indicated they hadn’t put the correct number in the system when the patient was admitted to the agency and it probably should be changed. 410 IAC 17-15-1(a)(1)”

“Contact info for primary care practitioner CFR(s): 484.110(a)(5) Contact information for the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA; and This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the correct physician was listed on the plan of care in 1 of 8 active record reviews. (Patient #5) Findings include: 1. A review of an agency’s policy dated revised April 2019 titled, ‘CONTENTS OF CLINICAL RECORD’ Policy No. 4-047.1-.3 revealed, “PURPOSE To outline the requirements and components of a clinical record … PROCEDURE 1. … W. Name, address and telephone number of patient’s primary care practitioner … “ 2. A review of the clinical record for Patient #5 revealed a Home Health Certification and Plan of Care document for the certification period of 02/03/2024 – 04/02/2024 which evidenced the attending physician was Person CC. 3. On 03/04/2024 at 9:59 AM this writer phoned Entity S to interview CC and to request copies of medications, the physician listed on the plan of care (POC), Person EE indicated Patient #5 was not a patient at that clinic. 4. On 03/05/2024 at 3:38 PM, the clinical manager indicated Patient #5 is being followed by Person DD, a physician. The clinical manager indicated they needed to change that in the record and indicated Person DD had been following Patient #5 for a couple of months. 410 IAC 17-15-1(a)(2)”

“Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure a discharge summary was sent to the ordering physician in 1 of 2 discharged clinical records reviewed. (Patient #2) Findings include: 1. A review of an agency’s policy dated revised April 2019 titled, ‘DISCHARGE CRITERIA AND PROCESS’ Policy No. 4-045.1-.3 revealed, “PURPOSE To outline the process for a discharging a patient from service .. Discharge … Criteria 1. Services will be terminated when the patient meets one (1) or more discharge criteria … D. The patient or family refuses … PROCEDURE … 2. A discharge summary is completed .. 5. The decision to terminate … must be documented in the clinical record … notification to the … patient’s physician … 8. … A discharge summary will be completed for all discharged patients … “ 2. A review of the clinical record for Patient #2, with a start of care date of 11-21-2022 which contained an OASIS (Outcome and Assessment Information Set is the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality) Discharge Non-visit assessment dated 10/06/2023, electronically signed by Person B on 10/06/2023. The clinical record for Patient #2 failed to evidence a discharge order and/or a discharge summary. 3. On 02/29/2024 at 1:25 the administrator indicated a discharge order is required and a discharge summary is sent to the physician when a patient requests to be discharged. 410 IAC 17-15-1(a)(6)”